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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72179

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

Open FDA event record

Event summary

Timeline bucket
September 12, 2015
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
US Compounding Inc

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

59 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 59

ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic use, Rx.only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032.

D-0236-2016
Recall number
D-0236-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
3 dropper bottles

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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150209@41 BUD: 10/2/2015, 20150909@2 BUD: 10/9/2015

Distribution pattern

Nationwide

drug · product 2 of 59

Alprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC: 62295-3253-05.

D-0237-2016
Recall number
D-0237-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
82 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150408@10 BUD: 1/27/2015; 20151407@11 BUD: 1/10/2015; 20151604@8 9/16/2015; 20152703@2 9/16/2015

Distribution pattern

Nationwide

drug · product 3 of 59

Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-10

D-0238-2016
Recall number
D-0238-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
19,494 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150104@4 BUD: 9/27/2015; 20150105@1 BUD: 10/27/2015; 20150107@25 BUD: 12/27/2015; 20150306@44 BUD: 11/29/2015; 20150704@49 BUD: 10/3/2015; 20150705@5 BUD: 11/1/2015; 20151106@17 BUD: 12/7/2015; 20151305@5 BUD: 11/8/2015; 20151806@19 BUD: 12/13/2015; 20152005@29 BUD: 11/15/2015; 20152205@7 BUD: 11/16/2015

Distribution pattern

Nationwide

drug · product 4 of 59

Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-02

D-0239-2016
Recall number
D-0239-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
5,514 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150206@41 BUD: 11/28/2015; 20151603@58 BUD: 9/12/2015; 20152007@43 BUD: 1/16/2016; 20152104@41 BUD: 10/18/2015

Distribution pattern

Nationwide

drug · product 5 of 59

Betamethasone SP, 2 mL (6 mg/mL),10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3240-07

D-0240-2016
Recall number
D-0240-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
100 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150806@9 BUD: 12/5/2015; 20152107@38 BUD: 1/17/2016

Distribution pattern

Nationwide

drug · product 6 of 59

Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3016-02

D-0241-2016
Recall number
D-0241-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
6,008 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150107@27 BUD:12/28/2015; 20150704@5 BUD: 10/4/2015; 20152005@22 BUD: 11/16/2015

Distribution pattern

Nationwide

drug · product 7 of 59

Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL), 5 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3254-05

D-0242-2016
Recall number
D-0242-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
96 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20152303@7 BUD: 9/19/2015

Distribution pattern

Nationwide

drug · product 8 of 59

Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3019-07

D-0243-2016
Recall number
D-0243-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
589 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20151205@11 BUD: 11/7/2015; 20151806@11 BUD: 12/15/2015

Distribution pattern

Nationwide

drug · product 9 of 59

Cyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottle, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3049-03

D-0244-2016
Recall number
D-0244-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
135 bottles

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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150707@5 BUD: 1/3/2016

Distribution pattern

Nationwide

drug · product 10 of 59

Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For topical ophthalmic use, Rx. only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3044-07

D-0245-2016
Recall number
D-0245-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
1,198 bottles

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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20152707@22 BUD: 10/25/2015; 20150707@9 BUD: 10/5/2015; 20152906@15 BUD: 9/27/2015; 20152907@2 BUD: 10/27/2015

Distribution pattern

Nationwide

drug · product 11 of 59

Cyclopent/PE/Tropic 2mL (1%/2.5%/0.25%), 2 mL dropper bottles; For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02

D-0246-2016
Recall number
D-0246-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
820 bottles

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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20151806@22 BUD: 12/15/2015; 20152306@36 BUD: 12/20/2015

Distribution pattern

Nationwide

drug · product 12 of 59

Dapiprazole (Diluent+Powder) 0.5% in 5 mL vial, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0201-99

D-0247-2016
Recall number
D-0247-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
2,984 bottles

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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150506@6 BUD: 11/28/2015; 20150805@40 BUD: 10/31/2015; 20151206@7 BUD: 12/5/2015; 20151704@21 BUD: 10/10/2015; 20152003@43 BUD: 9/12/2015

Distribution pattern

Nationwide

drug · product 13 of 59

Dex LA 8 (Dexamethasone acetate (8 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02

D-0248-2016
Recall number
D-0248-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
4,333 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150107@23 BUD: 12/28/2015; 20151305@43 BUD: 11/9/2015; 20151307@18 BUD: 1/9/2016; 20152204@33 BUD: 10/19/2015; 20152606@1 BUD: 12/22/2015; 20153003@34 BUD: 9/26/2015

Distribution pattern

Nationwide

drug · product 14 of 59

Dex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, 4 mg/mL),30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3057-06

D-0249-2016
Recall number
D-0249-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
854 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150705@1 BUD: 11/2/2015; 20151706@49 BUD: 12/14/2015; 20152204@21 BUD: 10/19/2015; 20152303@26 BUD: 9/19/2015

Distribution pattern

Nationwide

drug · product 15 of 59

Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or IM Use Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3227-02

D-0250-2016
Recall number
D-0250-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
235 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20151407@13 BUD: 1/10/2016

Distribution pattern

Nationwide

drug · product 16 of 59

ePHEDrine Sulfate PF (50 mg/10 mL), 10 mL Single-Use Syringe, For IV or IM Use Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3084-07

D-0251-2016
Recall number
D-0251-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
12,191 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20151706@45 BUD: 12/14/2015; 20151707@16 BUD: 1/13/2016; 20150904@17 BUD: 10/6/2015; 20151703@19 BUD: 9/13/2015; 20153003@7 BUD: 9/26/2015; 20153006@42 BUD: 12/27/2015

Distribution pattern

Nationwide

drug · product 17 of 59

Fentanyl PF 50 mL (25 mcg/mL), 10 mL Single Use Syringe, For IV, IM or SC injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0002-50

D-0252-2016
Recall number
D-0252-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
711 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150604@20 BUD: 10/3/2015; 20152306@20 BUD: 12/20/2015; 20152403@28 BUD: 9/20/2015

Distribution pattern

Nationwide

drug · product 18 of 59

Glycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe, For IM or IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3082-05

D-0253-2016
Recall number
D-0253-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
14,325 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150306@57 BUD: 11/30/2015; 20151305@40 BUD: 11/9/2015; 20151404@36 BUD: 10/11/2015; 20151603@3 BUD: 9/12/2015; 20152005@40 BUD: 11/16/2015; 20153003@10 BUD: 9/26/2015

Distribution pattern

Nationwide

drug · product 19 of 59

HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3083-99

D-0254-2016
Recall number
D-0254-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
7,852 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150806@22 BUD: 12/5/2015; 20150106@12 BUD: 11/28/2015; 20150106@20 BUD: 11/28/2015; 20150604@2 BUD: 10/3/2015; 20150604@2 BUD: 10/3/2015; 20150607@9 BUD: 1/2/2016; 20150806@22 BUD: 12/5/2015; 20151304@13 BUD: 10/10/2015; 20151506@22 BUD: 12/12/2015; 20152007@4 BUD: 1/16/2016; 20152206@20 BUD: 12/19/2015; 20152303@11 BUD: 9/19/2015; 20152303@2 BUD: 9/19/2015; 20152704@2 BUD: 10/24/2015; 20152707@3 BUD: 1/23/2016; 20152707@9 BUD: 1/23/2016; 20152303@11 BUD: 9/19/2015

Distribution pattern

Nationwide

drug · product 20 of 59

Hyaluronic Acid/Lidocaine PF (20 mg/1%), 2 mL Single-Use Syringe , For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3087-02

D-0255-2016
Recall number
D-0255-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
5,118 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150906@32 BUD: 12/6/2015, 20150906@33 BUD: 12/6/2015, 20151105@45 BUD: 11/7/2015, 20151205@12 BUD: 11/8/2015, 20151404@39 BUD: 10/11/2015

Distribution pattern

Nationwide

drug · product 21 of 59

Hyaluronic Acid/Lidocaine PF (60 mg/2%), 3 mL Single Use Syringe, For Intra-Articular Injection , Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3249-03

D-0256-2016
Recall number
D-0256-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
531 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20151105@39 BUD: 11/7/2015

Distribution pattern

Nationwide

drug · product 22 of 59

Hyaluronic Acid/Lidocaine (20 mg/1%/2 mL), 3 mL Single Use Syringe, For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01

D-0257-2016
Recall number
D-0257-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
105 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20151806@30 BUD: 11/7/2015, 20152306@38 BUD: 11/7/2015, 20151806@29 BUD: 11/7/2015, 20151903@30 BUD: 9/15/2015

Distribution pattern

Nationwide

drug · product 23 of 59

Hyaluronidase PF (150 units/mL) in 1 mL Single-Use Vial, Not for IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01

D-0258-2016
Recall number
D-0258-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
1,096 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150608@1 BUD: 10/5/2015, 20152707@4 BUD: 9/23/2015

Distribution pattern

Nationwide

drug · product 24 of 59

Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3294-06

D-0259-2016
Recall number
D-0259-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
103 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150405@59 BUD: 10/31/2015

Distribution pattern

Nationwide

drug · product 25 of 59

L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01

D-0260-2016
Recall number
D-0260-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
1,706 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20151906@10 BUD: 9/17/2015

Distribution pattern

Nationwide

drug · product 26 of 59

Lidocaine 1% PF(100 mg/10 mL),10 mL Single Use Syringe, For IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3099-07

D-0261-2016
Recall number
D-0261-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
7,320 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150104@21 BUD: 9/28/2015, 20150406@26 BUD: 12/1/2015, 20151704@1 BUD: 10/14/2015, 20152004@10 BUD: 10/17/2015

Distribution pattern

Nationwide

drug · product 27 of 59

Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection or IV Injection After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3104-07

D-0262-2016
Recall number
D-0262-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
1,421 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150505@1 BUD: 10/31/2015

Distribution pattern

Nationwide

drug · product 28 of 59

MedroxyPROGESTERone/Lidocaine (150 mg/mL/1%) 10 mL Multi-Dose Vial, For IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3113-07

D-0263-2016
Recall number
D-0263-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
439 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150705@13 BUD: 11/3/2015, 20151805@36 BUD: 11/14/2015

Distribution pattern

Nationwide

drug · product 29 of 59

Methylcobalamin (12.5 mg/mL), 2.5 mL Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3251-04.

D-0264-2016
Recall number
D-0264-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20152105@38 BUD: 11/17/2015, 20152705@34 BUD: 11/23/2015

Distribution pattern

Nationwide

drug · product 30 of 59

MethylPREDNISolone (100 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3115-07

D-0265-2016
Recall number
D-0265-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
3,629 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150806@41 BUD: 12/5/2015, 20151205@67 BUD: 11/8/2015, 20151504@24 BUD: 10/12/2015, 20152306@30 BUD: 12/20/2015, 20152603@27 BUD: 9/22/2015

Distribution pattern

Nationwide

drug · product 31 of 59

MethylPREDNISolone PF (80 mg/mL), 1 mL Single Use Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3119-01.

D-0266-2016
Recall number
D-0266-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
22,627 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150806@35 BUD: 12/5/2015, 20151006@34 BUD: 12/7/2015, 20152303@42 BUD: 9/19/2015, 20152704@16 BUD: 10/24/2015, 20152906@26 BUD: 12/26/2015, 20153007@19 BUD: 1/26/2016, 20151703@6 BUD: 9/13/2015, 20151806@12 BUD: 12/15/2015

Distribution pattern

Nationwide

drug · product 32 of 59

Methylprednisolone/Lidocaine (40 mg/mL/1%) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3122-07

D-0267-2016
Recall number
D-0267-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
11,363 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150707@31 BUD: 1/3/2016, 20150707@36 BUD: 1/3/2016, 20151106@19 BUD: 12/8/2015, 20151604@24 BUD: 10/13/2015, 20151606@20 BUD: 12/13/2015, 20151805@60 BUD: 11/14/2015, 20152105@35 BUD: 11/17/2015, 20153103@13 BUD: 9/27/2015

Distribution pattern

Nationwide

drug · product 33 of 59

MIC Combo (Methionine 25 mg/mL, Inositol 50 mg/mL, Choline chloride 50 mg/mL, Cyanocobalamin 1000 mcg/mL), 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3127-06.

D-0268-2016
Recall number
D-0268-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
1,939 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Numbers: 20150705@32 BUD: 11/2/2015, 20151304@17 BUD: 10/10/2015, 20151905@56 BUD: 11/15/2015, 20152004@9 BUD: 10/17/2015

Distribution pattern

Nationwide

drug · product 34 of 59

MIC-Combo, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3127-06.

D-0269-2016
Recall number
D-0269-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
1,736 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20150105@18 BUD: 10/28/2015, 20150805@34 BUD: 11/4/2015, 20152603@12 BUD: 9/21/2015, 20153004@20 BUD: 10/27/2015, 20150805@34 BUD: 11/4/2015, 20152603@12 BUD: 9/21/2015, 20153004@20 BUD: 10/27/2015

Distribution pattern

Nationwide

drug · product 35 of 59

Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2171-02

D-0270-2016
Recall number
D-0270-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
5,919 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20151008@2 BUD: 2/6/2016, 20151307@2 BUD: 1/9/2016, 20153107@27 BUD: 1/27/2016

Distribution pattern

Nationwide

drug · product 36 of 59

Neostigmine (5 mg/5 mL), 5 mL Single Use Syringe, For IM, SC or Slow IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3132-05

D-0271-2016
Recall number
D-0271-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
15,640 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20150106@48 BUD: 11/28/2015, 20150106@49 BUD: 11/28/2015, 20150306@37 BUD: 11/30/2015, 20150906@50 BUD: 12/6/2015, 20150906@7 BUD: 12/5/2015, 20151208@32 BUD: 2/8/2016, 20152304@2 BUD: 10/20/2015, 20152804@6 BUD:10/24/2015

Distribution pattern

Nationwide

drug · product 37 of 59

Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3137-02

D-0272-2016
Recall number
D-0272-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
8,218 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20150604@4 BUD: 10/3/2015, 20152205@1 BUD: 11/18/2015, 20152303@3 BUD: 9/19/2015, 20150604@1 BUD: 10/3/2015, 20151304@27 BUD: 9/19/2015, 20151506@19 BUD: 12/12/2015, 20151506@27R BUD: 11/28/2015, 20151603@2 BUD: 9/12/2015, 20152004@13 BUD: 10/17/2015, 20152206@13 BUD: 12/19/2015, 20152906@7 BUD: 12/26/2015

Distribution pattern

Nationwide

drug · product 38 of 59

Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3155-01

D-0273-2016
Recall number
D-0273-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
542 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20151506@31 BUD: 9/13/2015

Distribution pattern

Nationwide

drug · product 39 of 59

Phenylephrine 10% PF Ophthalmic Solution, 3 mL dropper bottle, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3273-03.

D-0274-2016
Recall number
D-0274-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
862 bottles

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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20151803@4 BUD: 9/14/2015, 20152005@19 BUD: 11/16/2015, 20152307@15 BUD: 1/19/2016, 20153003@4 BUD: 9/26/2015

Distribution pattern

Nationwide

drug · product 40 of 59

Phenylephrine (1 mg/mL), 5 mL Multi-Dose Vial, For SC, IM, IV or penile injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3289-05

D-0275-2016
Recall number
D-0275-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
11 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20150904@11 BUD: 10/6/2015

Distribution pattern

Nationwide

drug · product 41 of 59

Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3159-07

D-0276-2016
Recall number
D-0276-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
14,580 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20150806@1 BUD: 12/5/2015, 20150806@2 BUD: 12/5/2015, 20151105@4 BUD: 11/7/2015, 20151105@6 BUD: 11/7/2015, 20151407@3 BUD: 1/10/2016, 20151603@1 BUD: 9/12/2015, 20151805@25 BUD: 11/14/2015, 20151805@28 BUD: 11/14/2015, 20152206@17 BUD: 12/19/2015, 20152707@1 BUD: 1/23/2016, 20153003@1 BUD: 9/26/2015, 20152003@2 BUD: 9/26/2015

Distribution pattern

Nationwide

drug · product 42 of 59

Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3272-03

D-0277-2016
Recall number
D-0277-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
3,860 dropper bottles

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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20150206@3 BUD: 11/29/2015, 20150306@51 BUD: 11/30/2015, 20151106@28 BUD: 12/8/2015, 20151404@4 BUD: 10/11/2015, 20151606@3 BUD: 12/13/2015

Distribution pattern

Nationwide

drug · product 43 of 59

Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653

D-0278-2016
Recall number
D-0278-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
2 bottles

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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20152406@3 BUD: 9/12/2015, 20153108@16 BUD: 11/29/2015

Distribution pattern

Nationwide

drug · product 44 of 59

Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For Topical Ophthalmic Use, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653

D-0279-2016
Recall number
D-0279-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
1 bottle

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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20150209@16 BUD: 10/2/2015

Distribution pattern

Nationwide

drug · product 45 of 59

Succinylcholine Chloride (200 mg/10 mL), 10 mL Single Use Syringe (20 mg/mL), For IV use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3292-07

D-0280-2016
Recall number
D-0280-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
1,590 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20152606@4 BUD: 9/23/2015, 20151108@49 BUD: 11/9/2015

Distribution pattern

Nationwide

drug · product 46 of 59

Testosterone cypionate, USP (250 mg/mL), 10 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2131-07

D-0281-2016
Recall number
D-0281-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
2,524 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20150306@41 BUD: 11/30/2015, 20150505@56 BUD: 11/1/2015, 20150605@21 BUD: 11/2/2015, 20151607@33 BUD: 1/12/2015, 20152104@9 BUD: 10/18/2015, 20152206@24 BUD: 12/19/2015, 20151404@26 BUD: 10/11/2015, 20152104@9 BUD: 10/18/2015

Distribution pattern

Nationwide

drug · product 47 of 59

Testosterone EO-Pro-Cyp 220 (220 mg/mL) 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2169-06

D-0282-2016
Recall number
D-0282-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
1,386 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20151006@46 BUD: 12/7/2015, 20151607@40 BUD: 1/12/2016, 20152005@32 BUD: 11/16/2015, 20152304@28 BUD: 10/20/2015, 20152304@5 BUD: 10/20/2015, 20152606@2 BUD: 12/22/2015, 20152907@16 BUD: 1/23/2016

Distribution pattern

Nationwide

drug · product 48 of 59

Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate 1.57 mg, Manganese Sulfate monohydrate USP 0.308 mg, Chromic Chloride hexahydrate USP 0.0205 mg), 10 mL Multi-Dose Vial, For IV Injection After Dilution, Dilute Before IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3201-07

D-0283-2016
Recall number
D-0283-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
1,093 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20152804@35 BUD: 10/25/2015, 20150505@26 BUD: 11/1/2015

Distribution pattern

Nationwide

drug · product 49 of 59

Triamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3203-07

D-0284-2016
Recall number
D-0284-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
1,244 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20150605@28 BUD: 11/2/2015, 20150607@38 BUD: 1/2/2016, 20150906@3 BUD: 12/6/2015

Distribution pattern

Nationwide

drug · product 50 of 59

Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3204-07

D-0285-2016
Recall number
D-0285-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
980 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20150204@18 BUD: 9/29/2015, 20150906@38 BUD: 12/6/2015

Distribution pattern

Nationwide

drug · product 51 of 59

Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3205-06

D-0286-2016
Recall number
D-0286-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
13,843 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot: 20150204@7 BUD: 9/29/2015, 20150304@1 BUD: 9/29/2015, 20150604@23 BUD: 10/3/2015, 20150807@50 BUD: 1/4/2016, 20150906@23 BUD: 12/6/2015, 20150906@24 BUD: 12/6/2015, 20152005@42 BUD: 11/16/2015, 20152206@52 BUD: 12/19/2015, 20152406@14 BUD: 12/21/2015, 20152603@26 BUD: 9/22/2015, 20152804@20 BUD: 10/25/2015, 20152904@20 BUD: 10/26/2015, 20152907@8 BUD: 1/25/2016, 20151603@56 BUD: 9/12/2015, 20152406@30 BUD: 12/21/2015

Distribution pattern

Nationwide

drug · product 52 of 59

Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3206-01

D-0287-2016
Recall number
D-0287-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
33,778 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20150608@19 BUD: 2/2/2016, 20150807@35 BUD: 1/4/2016, 20152104@12 BUD: 10/1//2015, 20150105@2 BUD: 10/28/2015, 20150605@36 BUD: 11/2/2015, 20150607@26 BUD: 1/2/2016, 20150904@32 BUD: 10/6/2015, 20150906@35 BUD: 12/6/2015, 20151506@45 BUD: 12/12/2015, 20151603@43 BUD: 9/12/2015, 20152204@15 BUD: 10/19/2015, 20152506@35 BUD: 12/22/2015, 20152907@1 BUD: 1/25/2016

Distribution pattern

Nationwide

drug · product 53 of 59

Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ alprostadil USP 10 mcg/mL), 5 mL Multi-Dose Vial, For Penile Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3256-05

D-0288-2016
Recall number
D-0288-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
797 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20151305@17 BUD: 9/16/2015, 20151504@18 BUD: 9/16/2015, 20151903@13 BUD: 9/12/2015, 20151903@13 BUD: 9/12/2015, 20152107@3 BUD: 1/16/2016, 20152204@6 BUD: 9/16/2015, 20152403@13 BUD: 9/12/2015, 20152403@21 BUD: 9/16/2015, 20152904@8 BUD: 9/16/2015

Distribution pattern

Nationwide

drug · product 54 of 59

Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3298-02

D-0289-2016
Recall number
D-0289-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
1,833 bottles

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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20151606@11 BUD: 12/13/2015

Distribution pattern

Nationwide

drug · product 55 of 59

Tropicamide 1%/Phenylephrine 2.5% (tropicamide USP 10 mg/ phenylephrine HCL USP 25 mg), 10 mL Ophthalmic Dropper, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3214-07

D-0290-2016
Recall number
D-0290-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
751 bottles

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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20151307@4 BUD: 1/9/2016, 20151805@30 BUD: 11/14/2015, 20152004@23 BUD: 10/17/2015

Distribution pattern

Nationwide

drug · product 56 of 59

Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0209-64

D-0291-2016
Recall number
D-0291-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
494 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20152306@13 BUD: 12/20/2015

Distribution pattern

Nationwide

drug · product 57 of 59

Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3277-06

D-0292-2016
Recall number
D-0292-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
55 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20151703@26 BUD: 9/13/2015, 20151703@26 BUD: 9/13/2015

Distribution pattern

Nationwide

drug · product 58 of 59

Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2815-10

D-0293-2016
Recall number
D-0293-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
2 dropper bottles

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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20150209@40 BUD: 9/16/2015

Distribution pattern

Nationwide

drug · product 59 of 59

Zinc Sulfate (1 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3226-07

D-0294-2016
Recall number
D-0294-2016
Initiated
September 12, 2015
Classification
Class II
Status
Terminated
Recalling firm
US Compounding Inc
Quantity
562 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information

Lot Code: 20150804@1 BUD: 10/5/2015, 20150907@1 BUD: 1/5/2016

Distribution pattern

Nationwide