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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75289

97 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 21, 2016
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Wells Pharmacy Network LLC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

97 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 97

Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL and d) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

D-0327-2017
Recall number
D-0327-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
a) 694 vials b) 389 vials c) 695 vials d) 5193 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot codes: 03282016@16, 03302016@4, 04042016@10, 04262016@3, 05162016@2, 06032016@2, 07062016@10, 08262016@2 b) Known lot code: 04012016@4, 04182016@6, 04282016@7, 05022016@4, 06142016@19, 08102016@22. c) Known lot code: 04042016@7, 05022016@9, 05272016@2, 06272016@13, 07292016@8, 08192016@10 d) Known lot code: 03242016@12, 04082016@6, 04142016@2, 04192016@5, 04272016@4, 05092016@4, 05232016@17, 06122016@6, 06082016@2, 06142016@148, 06162016@9, 06172016@13, 06232016@78, 06282016@31, 07122016@20, 08012016@25, 08032016@12, 08042016@13.

Distribution pattern

Nationwide

drug · product 2 of 97

ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 250 mg/mL 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0328-2017
Recall number
D-0328-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
157 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known Lot No. 03282016@22, 05162016@5, 07252016@16. Known lot codes: 03282016@22, 05162016@5, 07262016@16

Distribution pattern

Nationwide

drug · product 3 of 97

Testosterone Enanthate in Grapeseed Oil Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0329-2017
Recall number
D-0329-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
1,250 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot codes: 03282016@3, 04132016@1, 05262016@3, 06242016@97, 07282016@1

Distribution pattern

Nationwide

drug · product 4 of 97

QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, a) 2 mL and 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

D-0330-2017
Recall number
D-0330-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
a) 1,312 vials and b) 3,354 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 03292016@12, 0422016@10, 04222016@10, 05052016@33, 05122016@11, 05132016@19, 05242016@2, 06212016@17, 07262016@36, 09072016@21, 09142015@17 b) Known lot code: 03242016@9, 04112016@10, 04212016@19, 05042016@20, 05132016@21, 05202016@71, 06152016@7, 07122016@21, 08032016@17, 09092016@35.

Distribution pattern

Nationwide

drug · product 5 of 97

Phenylephrine HCl Injectable, 1 mg/mL (0.1%), 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0331-2017
Recall number
D-0331-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
1,968 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot codes: 03292016@3, 04202016@4, 05162016@6, 06102016@9, 07202016@44, 08032016@38

Distribution pattern

Nationwide

drug · product 6 of 97

MIC Combo - Standard 15 mg/50 mg/100 mg/mL Injectable, 30 mL vials, Compounded by Wells Pharmacy, Ocala, FL

D-0332-2017
Recall number
D-0332-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
308 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03292016@5, 04122016@76, 04202016@5, 05182016@2, 06102016@2, 06282016@71, 09092016@1

Distribution pattern

Nationwide

drug · product 7 of 97

Nicotinamide Adenine Dinucleotide (NADH) - Lyophilized (P.F.) 100 mg Injectable, Compounded by Wells Pharmacy, Ocala, FL

D-0333-2017
Recall number
D-0333-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03302016@13, 06302016@95, 08082016@58.

Distribution pattern

Nationwide

drug · product 8 of 97

ULTRA-TEST in Grapeseed Oil (CYP 90%/PROP 10%) Injectable, 200 mg/mL, 8 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0334-2017
Recall number
D-0334-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
714 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03302016@5, 04202016@2, 05172016@5, 06082016@44, 06102016@6, 08042016@14

Distribution pattern

Nationwide

drug · product 9 of 97

ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0335-2017
Recall number
D-0335-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
325 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04152016@2, 05052016@2, 05192016@7, 07142016@28, 09122016@23

Distribution pattern

Nationwide

drug · product 10 of 97

Chorionic Gonadotropin, Lyophilized (HCG) 11,000 Unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0336-2017
Recall number
D-0336-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
10 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04052016@16, 04072016@26, 04142016@65, 05172016@105, 06062016@137, 06152016@28, 06232016@61, 07272016@56, 08192016@108, 09062016@127 Known vial lot code: 03252016@6, 03312016@1, 04042016@30, 05052016@134, 05092016@57, 06072016@32, 06172016@120, 07222016@26, 07222016@26, 08122016@3, 08252016@3.

Distribution pattern

Nationwide

drug · product 11 of 97

Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL

D-0337-2017
Recall number
D-0337-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
a) 24 vials, b) 91 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 03312016@6 b) Known lot code: 04222016@8, 15202016@85, 06302016@4, 08012016@32

Distribution pattern

Nationwide

drug · product 12 of 97

Testosterone Cypionate in Sesame Oil Injectable, 210 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0338-2017
Recall number
D-0338-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
21 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03312016@9

Distribution pattern

Nationwide

drug · product 13 of 97

Alprostadil 40 mcg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL

D-0339-2017
Recall number
D-0339-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
37 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 05092016@3, 07192016@8

Distribution pattern

Nationwide

drug · product 14 of 97

Arginine HCl 100 mg/mL Injectable,10 mL, Compounded by Wells Pharmacy Network, LLC, Ocala, FL

D-0340-2017
Recall number
D-0340-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
351 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 05122016@3, 07072016@15, 08302016@65

Distribution pattern

Nationwide

drug · product 15 of 97

Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy Network, LLC, Ocala, FL

D-0341-2017
Recall number
D-0341-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
30 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 06032016@7, 09092016@5

Distribution pattern

Nationwide

drug · product 16 of 97

B-complex + Vit C 20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy Network, LLC, Ocala, FL

D-0342-2017
Recall number
D-0342-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
180 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03252016@2, 04292016@11, 06122016@9, 07212016@11

Distribution pattern

Nationwide

drug · product 17 of 97

Bimix 30 mg/1 mg/mL Injectable, a) 5 mL and b) 10 mL vial, Compounded by Wells Pharmacy Network, LLC, Ocala, FL

D-0343-2017
Recall number
D-0343-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
a) 80 vials, b) 23 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04012016@7, 04252016@17, 05262016@13, 06142016@39, 08052016@13 b) Known lot code: 05242016@11, 09072016@18

Distribution pattern

Nationwide

drug · product 18 of 97

Carnitine-L 250 mg/mL Injectable, 30 mL vials, Rx only, Compounded by Wells Pharmacy, Ocala, FL

D-0344-2017
Recall number
D-0344-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
44 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 07222016@2, 08172016@1

Distribution pattern

Nationwide

drug · product 19 of 97

Ceftazidime, Lyophilized, Ophthalmic 2.25% Kit, Rx only, Compounded by Wells Pharmacy, Ocala , FL

D-0345-2017
Recall number
D-0345-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
46 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 06062016@118. Vial lot code 05272016@47

Distribution pattern

Nationwide

drug · product 20 of 97

Chorionic Gonadotropin (New York State), 11,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0346-2017
Recall number
D-0346-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
18 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 06072016@44, 07292016@92, 08092016@80, 09132016@33. Known vial lot code: 04042016@30, 07222016@26, 04042016@30, 08252016@3

Distribution pattern

Nationwide

drug · product 21 of 97

Chorionic Gonadotropin, Lyophilized, 3,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0347-2017
Recall number
D-0347-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
1753 kits (number of vials per kit vary)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04212016@46, 05232016@215, 05232016@216, 07052016@89, 08042016@103, 09132016@116. Known vial lot code: 04132016@91, 05162016@136, 06242016@96, 07282016@51, 09092016@20

Distribution pattern

Nationwide

drug · product 22 of 97

Chorionic Gonadotropin, Lyophilized, 5,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0348-2017
Recall number
D-0348-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
5277 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04142016@75, 04252016@52, 05042016@143, 05042016@158, 06092016@169, 06242016@158, 08022016@154, 08112016@56, 08252016@82, 09082016@41. Known vial lot code: 04062016@7, 04182016@49, 04292016@80, 04282016@43, 06012016@44, 06152016@57, 07132016@68, 08042016@35, 08192016@45, 08242016@33

Distribution pattern

Nationwide

drug · product 23 of 97

Chorionic Gonadotropin, Lyophilized, 6,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0349-2017
Recall number
D-0349-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
2,339 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code:04212016@49, 05262016@154, 06092016@181, 08082016@118, 08252016@89. Known vial lot code: 04142016@34, 05202016@55, 06032016@42, 08012016@41, 08192016@47.

Distribution pattern

Nationwide

drug · product 24 of 97

Chorionic Gonadotropin, Lyophilized, 7,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0350-2017
Recall number
D-0350-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
1,638 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code:04052016@14, 05162016@126, 06092016@173, 06202016@137, 08042016@97, 09132016@117. Known vial lot code: 03242016@31, 04262016@25, 06032016@44, 06202016@137, 07252016@56, 09092016@17.

Distribution pattern

Nationwide

drug · product 25 of 97

Chorionic Gonadotropin Lyophilized, 20,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0351-2017
Recall number
D-0351-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
908 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code:04212016@42, 06092016@164, 08122016@96. Known vial lot code: 04132016@96, 05242016@1, 08082016@50.

Distribution pattern

Nationwide

drug · product 26 of 97

Chorionic Gonadotropin+B12(C), Lyophilized, 10,000 unit + 40 mcg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0352-2017
Recall number
D-0352-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
724 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05042016@162, 06062016@122, 08192016@110. Known vial lot code: 04252016@168, 05252016@117, 08152016@40.

Distribution pattern

Nationwide

drug · product 27 of 97

Dexamethasone Sodium Phosphate 200 mg/mL, Injectable, Compounded by Wells Pharmacy, Ocala, FL

D-0353-2017
Recall number
D-0353-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
15 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 07082016@25.

Distribution pattern

Nationwide

drug · product 28 of 97

Dexamethasone Sodium Phosphate 24 mg/mL (2.4%), Injectable, 2 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0354-2017
Recall number
D-0354-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
16 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 08082016@45.

Distribution pattern

Nationwide

drug · product 29 of 97

DMSO (Dimethyl Sulfoxide) with Lidocaine 50%/0.5% mL Solution, 50 mL bottle, Compounded by Wells Pharmacy, Ocala, FL

D-0355-2017
Recall number
D-0355-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
438 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04132016@69, 04272016@9, 05142016@13, 06162016@129, 07052016@12, 07292016@2.

Distribution pattern

Nationwide

drug · product 30 of 97

Fluorescein/Indocyanine, Lyophilized (P.F.), 400 mg/15 mg, 1 mL, Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0356-2017
Recall number
D-0356-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
203 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 06082016@133. Known vial lot code: 05202016@4.

Distribution pattern

Nationwide

drug · product 31 of 97

Forskolin/PAPAV/PHEN/PGE1, 100 mcg/30 mcg/3 mcg/60 mcg/mL, 5 mL vial, Injectable, Compounded by Wells Pharmacy, Ocala, FL

D-0357-2017
Recall number
D-0357-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
22 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 05272016@18.

Distribution pattern

Nationwide

drug · product 32 of 97

Glutamine/ORNI/Arginine/LYS/CITRU+LIDO 75 mg/75 mg/150 mg/50 mg/100 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0358-2017
Recall number
D-0358-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
147 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 06232016@14, 07212016@2, 08012016@35, 08192016@11.

Distribution pattern

Nationwide

drug · product 33 of 97

Glutamine/Arginine/Carnitine 25 mg/100 mg/200 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0359-2017
Recall number
D-0359-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
137 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 07012016@10, 08032016@42, 08182016@11.

Distribution pattern

Nationwide

drug · product 34 of 97

Glutamine/ORNI/ARGIN/LYSINE/LIDO Injectable, 75 mg/75 mg/150 mg/150 mg/10 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0360-2017
Recall number
D-0360-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
199 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 06292016@9, 07252016@39, 08102016@24.

Distribution pattern

Nationwide

drug · product 35 of 97

Glutathione 200 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0361-2017
Recall number
D-0361-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
148 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 07252016@46, 08112016@19.

Distribution pattern

Nationwide

drug · product 36 of 97

Indocyanine Green (P.F.), 15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0362-2017
Recall number
D-0362-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
131 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 08232016@42. Known vial lot code: 08172016@45.

Distribution pattern

Nationwide

drug · product 37 of 97

Inositol/Choline/B-Complex+Leucine+CARN+CHROM+LIDO (LipoLean), Injectable, 30 mL vial, Compounded by Wells Pharmacy. Ocala, FL

D-0363-2017
Recall number
D-0363-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
433 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04132016@32, 05062016@4, 05312016@5, 06132016@93, 06282016@36, 08172016@5.

Distribution pattern

Nationwide

drug · product 38 of 97

Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0364-2017
Recall number
D-0364-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
189 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04062016@3, 04252016@4, 05172016@4, 06162016@6, 07212016@8.

Distribution pattern

Nationwide

drug · product 39 of 97

Methylcobalamin 1,000 mcg/mL Injectable, a) 10 mL vial and b) 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0365-2017
Recall number
D-0365-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
a) 499 vials b) 1214 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04062016@5, 05172016@1, 06162016@2, 07202016@47, 08222016@6 b) Known lot code: 04052016@1, 05032016@1, 05182016@1, 05262016@32, 06162016@13, 06232016@74, 07012016@18, 08092016@6, 09062016@33

Distribution pattern

Nationwide

drug · product 40 of 97

Methylcobalamin 5,000 mcg/mL Injectable, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0366-2017
Recall number
D-0366-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
265 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04152016@3, 05192016@1, 06132016@23, 07132016@10, 08112016@22, 09062016@32.

Distribution pattern

Nationwide

drug · product 41 of 97

Methylcobalamin Injectable (Dr. Hall Kit) - 1,000 mcg/mL, 30 mL vial Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0367-2017
Recall number
D-0367-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
7 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04292016@93, 07282016@26, 09082016@37. Known vial lot code: 04052016@1, 05262016@32, 08092016@6.

Distribution pattern

Nationwide

drug · product 42 of 97

MIC/B12(M) 15 mg/50 mg/100 mg/1 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0368-2017
Recall number
D-0368-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
633 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04222016@4, 05112016@24, 05162016@14, 06082016@8, 06222016@42, 07272016@8

Distribution pattern

Nationwide

drug · product 43 of 97

MIC/B12/CAR/CHR/LYS/DMG 25 mg/50 mg/50 mg/0.5 mg/50 mg/25 mcg/25 mg/25 mg/mL Injectable, 30 mL vial, Injectable, Compounded by Wells Pharmacy, Ocala, FL

D-0369-2017
Recall number
D-0369-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
106 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 06292016@10, 08092016@19, 08232016@5.

Distribution pattern

Nationwide

drug · product 44 of 97

MIC/B-COMP/(M)/CHROM/CARN, 20 mg/40 mg/50 mg/25 mcg/25 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0370-2017
Recall number
D-0370-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
933 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04082016@4, 05102016@1, 05172016@6, 06032016@3, 06092016@17, 06212016@42, 07012016@32, 07272016@16, 08172016@13, 4252016@21.

Distribution pattern

Nationwide

drug · product 45 of 97

MIC/BCOMP+CAR+ARG+CHR+LID 12.5 mg/25 mg/25 mg/25 mg/12.5 mg/0.2 mg/20 mg/mL Injectable, a) 10 mL and b) 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0371-2017
Recall number
D-0371-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
511 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: a) 04192016@7, 05132016@7, 07052016@19, 08102016@9 and b) 04262016@4, 05132016@9, 05192016@9, 05252016@25, 08122016@1.

Distribution pattern

Nationwide

drug · product 46 of 97

MIC/B-COMP+CARN+LIDO, 15 mg/30 mg/30 mg/85 mg/20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0372-2017
Recall number
D-0372-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
1716 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03302016@9, 04072016@15, 05022016@14, 05052016@5, 05162016@16, 06012016@11, 06092016@30, 06152016@15, 06212016@2, 07152016@8, 08042016@21.

Distribution pattern

Nationwide

drug · product 47 of 97

MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0373-2017
Recall number
D-0373-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
4 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 07132016@5.

Distribution pattern

Nationwide

drug · product 48 of 97

MIC/B-COMPLEX 15 mg/50 mg/100 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0374-2017
Recall number
D-0374-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
984 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04052016@5, 04082016@3, 04182016@37, 05032016@2, 05182016@3, 05232016@22, 06072016@18, 06282016@45, 07252016@52, 08262016@8.

Distribution pattern

Nationwide

drug · product 49 of 97

MIC/Chromium/B12(M) Injectable, 25 mg/50 mg/50 mg/25 mcg/1 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0375-2017
Recall number
D-0375-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
648 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03302016@8, 04152016@5, 05032016@15, 05262016@24, 06142016@1, 07202016@55.

Distribution pattern

Nationwide

drug · product 50 of 97

MIC+B12(M)+Carnitine 12.5 mg/50 mg/100 mg/1 mg/50 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0376-2017
Recall number
D-0376-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
159

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03252016@5, 04192016@8, 05242016@15, 06222016@28, 08102016@2.

Distribution pattern

Nationwide

drug · product 51 of 97

Mitomycin Solution Injectable, Sterile 0.02%, 200 mcg/mL, 1 mL syringe, Compounded by Wells Pharmacy, Ocala, FL

D-0377-2017
Recall number
D-0377-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
122 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04142016@107, 05242016@128

Distribution pattern

Nationwide

drug · product 52 of 97

Mitomycin Solution Injectable, Sterile 0.04%, 400 mcg/mL, 1 mL syringe, Compounded by Wells Pharmacy, Ocala, FL

D-0378-2017
Recall number
D-0378-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
41 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 05022016@160

Distribution pattern

Nationwide

drug · product 53 of 97

Mitomycin 20 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0379-2017
Recall number
D-0379-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
315 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05122016@84, 07012016@107. Known vial lot code: 04212016@149, 06082016@7.

Distribution pattern

Nationwide

drug · product 54 of 97

Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0380-2017
Recall number
D-0380-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
2,336 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04112016@201, 04202016@33, 05182016@46, 05232016@227, 06072016@55, 06092016@88, 06142016@60, 07012016@112, 07132016@142, 07292016@121, 07292016@129. Known vial lot code: 04062016@106, 04182016@10, 04262016@56, 05022016@189, 05102016@54, 05192016@84, 05242016@135, 06232016@70, 07012016@112, 07072016@94.

Distribution pattern

Nationwide

drug · product 55 of 97

NADH/Carnitine/Taurine/B12(M) Injectable, 100 mg/150 mg/150 mg/10 mg, Lyophilized Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0381-2017
Recall number
D-0381-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
219 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04072016@29, 08122016@103. Known vial lot code: 03302016@13, 03252016@16, 08082016@58, 08082016@67.

Distribution pattern

Nationwide

drug · product 56 of 97

Nandrolone Decanote (H), 200 mg/mL Injectable, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0382-2017
Recall number
D-0382-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
526 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04112016@16, 04282016@3, 05202016@6, 06132016@4, 07052016@1, 07272016@7.

Distribution pattern

Nationwide

drug · product 57 of 97

QUAD1(PAP/PHEN/ALPROS/ATRO) 0.9 mg/0.2 mg/20 mcg/0.01 mg/mL Injectable, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

D-0383-2017
Recall number
D-0383-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
a) 1,165 vials b) 2,217 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04122016@17, 04142016@14, 05112016@23, 06072016@17, 06232016@13, 07122016@41, 08052016@12 b) Known lot code: 03242016@8, 04142016@15, 05032016@11, 05262016@12, 06242016@11, 07122016@42, 08052016@11.

Distribution pattern

Nationwide

drug · product 58 of 97

QUAD2 (PAP/PHEN/ALPROS/ATRO) 9 mg/1 mg/10 mg/0.1 mg/mL Injectable a) 2 mL and b) 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0384-2017
Recall number
D-0384-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
a) 191 vials and b) 794 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04222016@8, 06142016@42, 08152016@17 b) Known lot code: 03312016@8, 05182016@15, 08092016@18

Distribution pattern

Nationwide

drug · product 59 of 97

QUAD4 (PAP/PHEN/ALPROS/ATRO) 30 mg/3 mg/60 mcg/0.2 mg/mL Injectable, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

D-0385-2017
Recall number
D-0385-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
114 vials and b) 1,017 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04072016@8, 06272016@22, 09082016@29 b) Known lot code: 04142016@16, 04272016@8, 06102016@13, 07062016@29, 08052016@1.

Distribution pattern

Nationwide

drug · product 60 of 97

Sermorelin Acetate 15 mg Injectable Kit., Compounded by Wells Pharmacy, Ocala, FL

D-0386-2017
Recall number
D-0386-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
568 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05182016@173, 07052016@148, 09062016@114. Known vial lot code: 04252016@165, 06102016@56, 08262016@42.

Distribution pattern

Nationwide

drug · product 61 of 97

Sermorelin Acetate 28 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0387-2017
Recall number
D-0387-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
330 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05182016@51, 05262016@146, 06212016@76, 08052016@74. Known vial lot code: 04252016@163, 05042016@87, 07192016@31.

Distribution pattern

Nationwide

drug · product 62 of 97

Sermorelin Acetate 9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0388-2017
Recall number
D-0388-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
629 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04212016@55, 06222016@106. Known vial lot code: 04142016@31, 06012016@50.

Distribution pattern

Nationwide

drug · product 63 of 97

Sermorelin Acetate/GHRP (2) & (6) 9 mg/3.15 mg/3.15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0389-2017
Recall number
D-0389-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
3,089 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05122016@180, 06132016@155, 06232016@147, 07062016@156, 07272016@68, 08232016@24, 09062016@74. Known vial lot code: 04212016@110, 052412016@76, 05312016@40, 06102016@52, 07152016@56, 08192016@20, 08102016@56.

Distribution pattern

Nationwide

drug · product 64 of 97

Sermorelin Acetate/GHRP (2) & (6) 9 mg/9 mg/9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0390-2017
Recall number
D-0390-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
1,319 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04072016@19, 05272016@55, 06102016@62, 09062016@75. Known vial lot code: 03302016@11, 050412016@98, 05172016@10, 08252016@18.

Distribution pattern

Nationwide

drug · product 65 of 97

Sermorelin Acetate/GHRP (2) 9 mg/9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0391-2017
Recall number
D-0391-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
158 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05182016@215, 09062016@92. Known vial lot code: 04252016@158, 082612016@45.

Distribution pattern

Nationwide

drug · product 66 of 97

Sermorelin Acetate/GHRP (2) Kit 6 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0392-2017
Recall number
D-0392-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
176 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04062016@170, 05272016@67, 09132016@98. Known vial lot code: 03302016@12, 050412016@84, 08222016@27.

Distribution pattern

Nationwide

drug · product 67 of 97

Sermorelin Acetate/GHRP (2)/Theanine 15 mg/5.4 mg/75 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0393-2017
Recall number
D-0393-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
1,255 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05162016@37, 06172016@161, 06242016@135, 08112016@121. Known vial lot code: 04202016@8, 05252016@33, 05312016@47, 08042016@39.

Distribution pattern

Nationwide

drug · product 68 of 97

Sermorelin Acetate/GHRP (2) 3 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0394-2017
Recall number
D-0394-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
3 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05272016@100. Known vial lot code: 05042016@94.

Distribution pattern

Nationwide

drug · product 69 of 97

Sermorelin Acetate/GHRP (2) 9 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala FL

D-0395-2017
Recall number
D-0395-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
2,264 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04152016@149, 05182016@176, 06172016@142, 07272016@83, 08232016@32, 09122016@138. Known vial lot code: 04072016@91, 04262016@27, 05272016@41, 07192016@29, 08192016@18, 09062016@44.

Distribution pattern

Nationwide

drug · product 70 of 97

Sermorelin Acetate/GHRP (6) 3 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0396-2017
Recall number
D-0396-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
106 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05272016@73. Known vial lot code: 05042016@91.

Distribution pattern

Nationwide

drug · product 71 of 97

Sermorelin Acetate/GHRP (6) 6 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0397-2017
Recall number
D-0397-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
1,232 kits (number of vials per kit vary by prescription)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04192016@24, 05172016@229, 06032016@136, 06222016@121, 06222016@148, 09132016@102. Known vial lot code: 03242016@27, 04202016@7, 05162016@141, 06032016@47, 05312016@53, 08222016@54.

Distribution pattern

Nationwide

drug · product 72 of 97

Sodium Bicarbonate, 8.4% Injectable, 30 mL MultiDose vial, Compounded by Wells Pharmacy, Ocala, FL

D-0398-2017
Recall number
D-0398-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
67 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04062016@4, 05232016@120, 06142016@9, 09122016@9.

Distribution pattern

Nationwide

drug · product 73 of 97

Testosterone Cypionate / Zinc Sulf in Grapeseed Oil Injectable, 200 mg/200 mcg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0399-2017
Recall number
D-0399-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
266 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04012016@2, 05052016@4, 06022016@13, 06102016@35, 07052016@6.

Distribution pattern

Nationwide

drug · product 74 of 97

Testosterone Cypionate in Grapeseed Oil Injectable, 100 mg/mL, a) 1mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

D-0400-2017
Recall number
D-0400-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
a ) 303 vials and b) 413 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04212016@5, 05102016@123, 05232016@21, 07132016@18 b) Known lot code: 04142016@7, 05042016@6, 05252016@2, 06222016@30, 07132016@25, 07282016@5.

Distribution pattern

Nationwide

drug · product 75 of 97

Testosterone Cypionate in Grapeseed Oil Injectable, 20 mg/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0401-2017
Recall number
D-0401-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
146 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04142016@5, 04292016@5, 05022016@6, 07062016@7.

Distribution pattern

Nationwide

drug · product 76 of 97

Testosterone Cypionate in Sesame Oil Injectable 200 mg/mL, a) 1 mL and b) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

D-0402-2017
Recall number
D-0402-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
a) 798 vials and b) 3,191 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 03202016@10, 04072016@85, 04182016@4, 05062016@5, 05262016@1, 06132016@1, 08112016@4 b) Known lot code: 03282016@6, 04122016@2, 04182016@33, 05092016@6, 05192016@3, 06022016@5, 06072016@3, 06172016@3, 06292016@2, 07112016@5, 07262016@29, 07292016@12.

Distribution pattern

Nationwide

drug · product 77 of 97

Testosterone Cypionate/Anastrozole Injectable, 200 mg/1 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0403-2017
Recall number
D-0403-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
203 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03242016@4, 04122016@1, 05102016@10, 06092016@4, 07062016@12, 08152016@3.

Distribution pattern

Nationwide

drug · product 78 of 97

Testosterone Propionate Injectable, 100 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0404-2017
Recall number
D-0404-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
469 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04042016@2, 04282016@1, 05262016@2, 06272016@8, 08162016@12.

Distribution pattern

Nationwide

drug · product 79 of 97

Titan Up (INOS/CHOL/LEU/CAR/CHRO/LID) Injectable 25 mg/25 mg/1.5 mg/25 mg/0.025 mg/10 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0405-2017
Recall number
D-0405-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
433 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03252016@4, 04012016@9, 04042016@9, 04132016@14, 05062016@3, 06022016@7, 06152016@22, 06292016@25, 07282016@12.

Distribution pattern

Nationwide

drug · product 80 of 97

TitanMax-MIC/12/CA/CH/L/D Injectable 25 mg/50 mg/50/0.5 mg/50 mg/25 mcg/25 mg/25 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0406-2017
Recall number
D-0406-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
18 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 07212016@15.

Distribution pattern

Nationwide

drug · product 81 of 97

Tri 1 (PAP/PHEN/ATROPINE) NR Injectable, 3.6 mg/0.4 mg/0.04 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

D-0407-2017
Recall number
D-0407-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
a) 257 vials and b) 460 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04072016@10, 05102016@18, 06232016@12, 08182016@26 b) Known lot code: 04122016@19, 05042016@18, 06142016@43, 07122016@40, 07262016@47.

Distribution pattern

Nationwide

drug · product 82 of 97

Tri 2 (PAP/PHEN/ATROPINE) NR Injectable, 30 mg/3 mg/0.3 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

D-0408-2017
Recall number
D-0408-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
a) 238 vials and b) 607 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 05042016@19, 06142016@28, 07262016@34, 09072016@22 b) Known lot code: 04112016@8, 05232016@2, 06212016@21, 07012016@22, 09082016@31.

Distribution pattern

Nationwide

drug · product 83 of 97

Trimix with Atropine Injectable 30 mg/3 mg/150 mcg/0.2 mg/mL, a) 2 mL b) 5 mL and 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

D-0409-2017
Recall number
D-0409-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
a) 6 vials, b) 19 vials and c) 41 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04042016@22 b) Known lot code: 07192016@3 c) Known lot code: 04112016@13.

Distribution pattern

Nationwide

drug · product 84 of 97

Trimix with Atropine Injectable 30 mg/3 mg/300 mcg/0.2 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0410-2017
Recall number
D-0410-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
3 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 07192016@8.

Distribution pattern

Nationwide

drug · product 85 of 97

Trimix with Atropine Injectable 30 mg/3 mg/60 mcg/0.2 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0411-2017
Recall number
D-0411-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04112016@6.

Distribution pattern

Nationwide

drug · product 86 of 97

Trimix Injectable 30 mg/2 mg/40 mcg, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0412-2017
Recall number
D-0412-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
42 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code:03292016@79, 05262016@15, 07082016@9, 09082016@25.

Distribution pattern

Nationwide

drug · product 87 of 97

Trimix Injectable 30 mg/2 mg/20 mcg, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

D-0413-2017
Recall number
D-0413-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
a) 56 vials and b) 48 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code:05182016@17, 07222016@16, 08182016@27 b) Known lot code:03312016@7, 05192016@23, 08032016@34.

Distribution pattern

Nationwide

drug · product 88 of 97

Trimix Injectable 17.65 mg/0.59 mg/5.9 mcg/mL a) 2 mL, b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

D-0414-2017
Recall number
D-0414-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
a) 2 vials b) 3 vials and c) 7 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 07192016@25 b) Known lot code 06202016@157 c) Known lot code: 05042016@16.

Distribution pattern

Nationwide

drug · product 89 of 97

Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

D-0415-2017
Recall number
D-0415-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
a) 9 vials and b) 78 vials, c) 210 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 07222016@15 b) Known lot code: 04122016@17, 05182016@16, 09082016@28 c) Known lot code: 04072016@13, 05192016@22, 06132016@36, 08032016@35.

Distribution pattern

Nationwide

drug · product 90 of 97

Trimix Injectable 30 mg/1 mg/25 mcg/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0416-2017
Recall number
D-0416-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
7 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 07192016@26.

Distribution pattern

Nationwide

drug · product 91 of 97

Trimix Injectable 30 mg/3 mg/100 mcg/mL, a) 5 mL and 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

D-0417-2017
Recall number
D-0417-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
a) 1 vial and b) 12 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 07192016@7 b) Known lot code: 04122016@18.

Distribution pattern

Nationwide

drug · product 92 of 97

Trimix Injectable 30 mg/3 mg/60 mcg/mL, a) 2 mL, b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

D-0418-2017
Recall number
D-0418-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
a) 2 vials,, b) 9 vials and 6 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 07192016@27 b) Knonw lot code: 06202016@162 c) Known lot code: 07262016@49.

Distribution pattern

Nationwide

drug · product 93 of 97

Tri-Test 200 (CEP 100-75-25) Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0419-2017
Recall number
D-0419-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
550 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04122016@4, 05042016@3, 06012016@8, 06212016@5, 07252016@22.

Distribution pattern

Nationwide

drug · product 94 of 97

Vitamin D3 in Sesame Oil Injectable 100,000 IU/mL, 5 mL, vial, Compounded by Wells Pharmacy, Ocala, FL

D-0420-2017
Recall number
D-0420-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
237 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04112016@23, 05132016@3, 06062016@7, 06272016@17.

Distribution pattern

Nationwide

drug · product 95 of 97

Vitamin D3 in Sesame Oil Injectable 50,000 IU/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0421-2017
Recall number
D-0421-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
335 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04202016@1, 05052016@6, 06062016@1, 08012016@34.

Distribution pattern

Nationwide

drug · product 96 of 97

Testosterone Cypionate in Grapeseed Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0422-2017
Recall number
D-0422-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
4 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04082016@6, 06012016@6, 06142016@148

Distribution pattern

Nationwide

drug · product 97 of 97

Testosterone Cypionate in Sesame Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0423-2017
Recall number
D-0423-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
3 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04182016@33, 06022016@5

Distribution pattern

Nationwide