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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83669

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

Open FDA event record

Event summary

Timeline bucket
August 12, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

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

100 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 100

S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX

D-0198-2020
Recall number
D-0198-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
2 x 30 mL 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

Lot #: S06272019DT@08, BUD: 9/27/2019

Distribution pattern

Nationwide in the USA

drug · product 2 of 100

S-ASCORBIC ACID 500MG/ML MDV SOLN (NON-CORN), packaged in a) 50ML, b) 5ML, c) 30ML, glass vial, RX Only, Red Mountain Compounding RX.

D-0199-2020
Recall number
D-0199-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
81 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

Lot #: a) S04112019DT@07,Exp 8/11/19; S05012019DT@01, 9/1/19; S05142019DT@13, 9/14/19; S05282019DT@07, 9/28/19; S06042019DT@05, 10/4/19; S06182019DH@15, 10/18/19; S07102019DT@13, 12/10/19; S07172019DT@09, 12/17/19 b) S04172019DT@01, 8/17/19; c) S07172019DT@09, 12/17/19

Distribution pattern

Nationwide in the USA

drug · product 3 of 100

S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 10ML dropper bottle, RX only, Red Mountain Compounding RX

D-0200-2020
Recall number
D-0200-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
2x 10 ml 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

Code information

Lot #: S07222019DH@09, Exp 8/22/19

Distribution pattern

Nationwide in the USA

drug · product 4 of 100

S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx only, Red Mountain Compounding RX.

D-0201-2020
Recall number
D-0201-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
6x10 ml, 1x50 ml dropper 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

Code information

Lot #: a) S06112019DH@22, Exp 9/11/19; S06202019DT@10, Exp 9/20/19; S07312019DH@07, Exp 10/31/19; b) S07302019DH@07, Exp 10/30/19

Distribution pattern

Nationwide in the USA

drug · product 5 of 100

S-ATROPINE 0.02% OPTHALMIC SOLUTION, 10 ML dropper bottle, RX only, Red Mountain Compounding RX

D-0202-2020
Recall number
D-0202-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
2x10 ml 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

Code information

Lot #: S05232019DH@03, Exp 8/23/19; S07172019DT@03,Exp 10/17/19;

Distribution pattern

Nationwide in the USA

drug · product 6 of 100

S-ATROPINE 0.5% OPTH SOLN, 10 ML dropper bottle, RX only, Red Mountain Compounding RX.

D-0203-2020
Recall number
D-0203-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x10 ml dropper 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

Code information

Lot #: S05232019DH@04, Exp 8/23/19

Distribution pattern

Nationwide in the USA

drug · product 7 of 100

S-B5/B6/B12M 100/50/10MG/ML MDV SOLN, 30ML glass vial, RX only, Red Mountain Compounding RX.

D-0204-2020
Recall number
D-0204-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
5x10 ml glass 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

Lot #: S05132019DH@02, Exp 8/13/19; S05142019DT@05, Exp 8/14/19; S07032019DT@10, Exp 10/3/19; S07182019DH@01, Exp 10/18/19

Distribution pattern

Nationwide in the USA

drug · product 8 of 100

S-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic container, For irrigation use only, Rx only, Red Mountain Compounding Rx.

D-0205-2020
Recall number
D-0205-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
4x1000 plastic containers

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

Lot #: S03142019DT@09, Exp 9/14/19; S05052019DH@04, Exp 11/5/19; S06192019DT@03, Exp 12/19/19; S06262019DT@12, Exp 12/26/19

Distribution pattern

Nationwide in the USA

drug · product 9 of 100

S-CALCIUM CHLORIDE 100MG/ML (PF) INJ SOLN, 10ml glass vial, Rx only, Red Mountain Compounding RX

D-0206-2020
Recall number
D-0206-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x10 glass 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

Lot #: S07092019DT@14, Exp 8/9/19

Distribution pattern

Nationwide in the USA

drug · product 10 of 100

S-CALCIUM GLUCONATE 10% INJECTION (PF), packaged in a) 10 ml b) 5ml glass vials, Red Mountain Compounding RX

D-0207-2020
Recall number
D-0207-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
18x10 ml and 1x5 ml glass 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

Lot #: a) 03072019DH@08, Exp 9/7/19; S04042019DT@04, Exp 10/4/19; S05012019DH@04, Exp 11/1/19; S05242019DT@12, Exp 11/24/19; S06182019DH@12 Exp 12/18/19; S06182019DH@32, Exp 12/18/19; S07152019DH@02, Exp 1/15/20; b) S06202019DT@05, Exp 12/20/19;

Distribution pattern

Nationwide in the USA

drug · product 11 of 100

S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV, 10 ml glass vial, Red Mountain Compounding Rx

D-0208-2020
Recall number
D-0208-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

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

Lot #: S07312019DH@15, Exp 8/31/19

Distribution pattern

Nationwide in the USA

drug · product 12 of 100

S-CYANOCOBALAMIN 1,000 MCG/ML MDV INJ SOLN, packaged in a) 10ml and b) 30 ml glass vial, Rx Only, Red Mountain Compounding Rx.

D-0209-2020
Recall number
D-0209-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
5x10 ml and 5x30 ml glass 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

Lot #: a) S05312019DT@03, Exp 8/31/19;S06032019DT@05, Exp 9/3/19 S06122019DT@07, Exp 9/12/19; b) S05312019DT@07, Exp 8/31/19; S06122019DT@07, Exp 9/12/19;S06252019DH@11, Exp 9/25/19; S07172019DT@01, Exp 10/25/19

Distribution pattern

Nationwide in the USA

drug · product 13 of 100

S-DEXTROSE/GLYCERIN/PHENOL 25/25/2.5% INJ SOLN, 30 ml glass vial, Rx Only, Red Mountain Compounding Rx

D-0210-2020
Recall number
D-0210-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
8x30 ml glass 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

Lot #: S07292019DH@13, Exp 8/29/19

Distribution pattern

Nationwide in the USA

drug · product 14 of 100

S-DEXPANTHENOL 250MG/ML MDV INJ SOLN, 30ML glass vials, RX Only, Red Mountain Compounding RX

D-0211-2020
Recall number
D-0211-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
37x30 ml glass 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

Lot #: S03072019DH@08; Exp 9/7/19; S02142019DH@08, Exp 8/14/19; S03072019DH@07, Exp 9/7/19; 03072019DH@08, 9/7/19; S03042019DH@07, Exp 9/4/19, S04172019DT@02, Exp 10/17/19; S05232019DT@10, Exp 11/23/19; S06242019DH@10, Exp 12/24/19; S07172019DT@07, Exp 1/17/20; S07242019DH@09, Exp 1/24/20

Distribution pattern

Nationwide in the USA

drug · product 15 of 100

S-DEXTROSE 50% MDV SOLN, 50 ML glass vial, RX Only, Red Mountain Compounding RX

D-0212-2020
Recall number
D-0212-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
5x50 ml glass 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

Lot #: S06092019DH@09, Exp 9/9/19; S06252019DT@11, 9/25/19; S07092019DT@07, Exp 10/9/19; S07092019DT@13, Exp 10/9/19;

Distribution pattern

Nationwide in the USA

drug · product 16 of 100

S-DMPS 50MG/ML INJ SOLN (PF), 5 ml glass vial, Rx Only, Red Mountain Compounding RX.

D-0213-2020
Recall number
D-0213-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x5 ml glass 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

Lot #: S05092019DH@06, Exp 8/9/19

Distribution pattern

Nationwide in the USA

drug · product 17 of 100

S-DMSO 100% (PF) STERILE SOLUTION; packaged in a) 50 ml and b) 10 ml glass vials, Rx Only, Red Mountain Compounding Rx

D-0214-2020
Recall number
D-0214-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
10x50m ml and 1x10 ml glass 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

Lot #:a) S04242019DT@15, Exp 10/24/19; S05012019DH@03, Exp 11/1/19; S05072019DT@10, Exp 11/7/19; S05072019DT@12, Exp 11/7/19; S06202019DT@03, Exp 12/20/19; S06202019DT@04, Exp 12/20/19; S07222019DH@05, Exp 07/22/2019 b) S06272019DT@06, Exp 12/27/19;

Distribution pattern

Nationwide in the USA

drug · product 18 of 100

S-E2/TEST CYP 0.4MG/1MG/MLMDV IN OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain Compounding Rx.

D-0215-2020
Recall number
D-0215-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x10 glass 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

Lot #: S06262019DT@08, Exp 9/26/19;

Distribution pattern

Nationwide in the USA

drug · product 19 of 100

S-E2/TEST CYP 1MG/4MG SESAME OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain Compounding Rx.

D-0216-2020
Recall number
D-0216-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
2x10 ml glass 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

Lot #: S05212019DT@06 Exp, 5/21/19; S06262019DT@08, Exp 6/26/19

Distribution pattern

Nationwide in the USA

drug · product 20 of 100

S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX.

D-0217-2020
Recall number
D-0217-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
3x50ml, 6x100ml glass 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

Lot #: a) S04232019DT@07, Exp 8/23/19; S07302019DH@09, Exp 11/30/19, b) S05142019DT@14, Exp 9/14/19; S06182019DH@30, Exp 10/18/19; S06182019DH@13, Exp 10/18/19;

Distribution pattern

Nationwide in the USA

drug · product 21 of 100

S-ESTRADIOL CYP 5MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10 ml, glass vials, Rx Only, Red Mountain Compounding RX

D-0218-2020
Recall number
D-0218-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
11 5ml and 10ml glass 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

Lot #: S05092019DH@08, Exp 8/9/19; S06112019DH@14, Exp 9/11/19; S07222019DH@04, Exp 10/22/19;

Distribution pattern

Nationwide in the USA

drug · product 22 of 100

S-ESTRADIOL VALERATE 20MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX.

D-0219-2020
Recall number
D-0219-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
2x5ml, 1x10 ml glass 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

Lot #: S07232019DH@10, Exp 10/23/19; S08012019DH@03, Exp 11/1/19;

Distribution pattern

Nationwide in the USA

drug · product 23 of 100

S-FOLIC ACID 10MG/ML MDV INJ; packaged in 30ml glass vials, Rx Only, Red Mountain Compounding RX.

D-0220-2020
Recall number
D-0220-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
5x30 ml glass 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

Lot #: S06162019DH@09, Exp 9/16/19; S06032019DT@01, Exp 9/30/19;

Distribution pattern

Nationwide in the USA

drug · product 24 of 100

S-GAT/KLAC/LIDO/PHE/TPMD 0.036/0.036/1.42/0.71/0.071%, OPTH GEL, 5ML dropper bottle, Red Mountain Compounding RX.

D-0221-2020
Recall number
D-0221-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1 5ml 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

Code information

Lot #: S07292019DH@08, Exp 9/29/19

Distribution pattern

Nationwide in the USA

drug · product 25 of 100

S-GENTAMICIN 480MG/1L, IRRIGATION SOLN, 1000ML plastic bottle, Red Mountain Compounding Pharmacy

D-0222-2020
Recall number
D-0222-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
2 1L- 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

Code information

Lot #: S07092019DT@18, Exp 8/23/19; S07312019DH@08, Exp 10/14/19

Distribution pattern

Nationwide in the USA

drug · product 26 of 100

S-GLUTATHIONE 200MG/3ML (PF) INHALATION SOLN, 3ML Prefilled Syringe, Red Mountain Compounding RX

D-0223-2020
Recall number
D-0223-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1, 3 ml prefilled syringe

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

Lot #: S07262019DH@02, Exp 8/26/19

Distribution pattern

Nationwide in the USA

drug · product 27 of 100

S-GLUTATHIONE 200MG/ML MDV, packaged in a) 12 ML b) 30 ml, glass vial, Red Mountain Compounding RX

D-0224-2020
Recall number
D-0224-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
2x12 ML and 79x30 ML 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

Lot #: a) S06252019DH@12, Exp 9/25/19; S07162019DT@02, Exp 10/16/19; b) S05162019DH@19, Exp 8/16/19; S05072019DT@08, Exp 8/7/19; S05082019DT@07, Exp 8/8/19; S05282019DT@08, Exp 8/28/19; S05312019DT@05, Exp 8/31/19; S06182019DH@11, Exp 9/18/19; S06242019DH@09, Exp 9/24/19; S07102019DT@06, Exp 10/10/19; S07162019DT@03, Exp 10/16/19; S07222019DH@10, Exp 10/22/19;

Distribution pattern

Nationwide in the USA

drug · product 28 of 100

S-GLYCERIN 72% INJECTION SOLN, 30ML glass vial, Red Mountain Compounding RX

D-0225-2020
Recall number
D-0225-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
5x30 ML 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

Lot #: S05142019DT@09, Exp 8/14/19; S07162019DT@14, Exp 10/16/19; S07232019DH@06, Exp 10/23/19

Distribution pattern

Nationwide in the USA

drug · product 29 of 100

S-HCG 1200U/ML MDV INJ SOLN; packaged in a) 5 ML, b) 10 ML, c) 30 ML glass vial. Red Mountain Compounding RX

D-0226-2020
Recall number
D-0226-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
81 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

Lot #:a) S07292019DH@01, Exp 9/29/19;S07232019DH@06, Exp 9/23/19;S06302019DH@05, Exp 8/30/19 b) S06112019DH@01, Exp 8/11/19; S06112019DH@11, Exp 8/11/19;S06142019DH@02, Exp 8/14/19; S06162019DH@01, 8/16/19,S06182019DH@34, Exp 8/18/19; S06242019DH@16, Exp 8/24/19; S06302019DH@05, Exp 8/30/19, S07102019DT@16, Exp 9/10/19; S07162019DH@02, Exp; 9/16/19, S07262019DH@03, Exp 9/26/19; S08022019DH@02, Exp 10/2/19; S07232019DH@06, Exp 9/23/19, c) S07102019DT@07, Exp 9/10/19;

Distribution pattern

Nationwide in the USA

drug · product 30 of 100

S-HYALURONIDASE 150U/ML INJ SOLN (PF), 5 ML vial, Red Mountain Compounding RX

D-0227-2020
Recall number
D-0227-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
2x5 ml 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

Lot #: S07232019DH@13, Exp 8/23/19; S07312019DH@14, Exp 8/31/19

Distribution pattern

Nationwide in the USA

drug · product 31 of 100

S-HYDROCHLORIC ACID 2MG/ML INJ SOLN, 50 ML glass vial, Red Mountain Compounding RX

D-0228-2020
Recall number
D-0228-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

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

Lot #: S06092019DH@03, Exp 9/9/19; S06162019DH@17, Exp 9/16/19

Distribution pattern

Nationwide in the USA

drug · product 32 of 100

S-HYDROGEN PEROXIDE 3% (PF) 30ML glass vial, Red Mountain Compounding RX

D-0229-2020
Recall number
D-0229-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
2x30 ml glass 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

Lot #: S05082019DT@02, Exp 8/8/19; S05112019DH@17, Exp 8/11/19

Distribution pattern

Nationwide in the USA

drug · product 33 of 100

S-HYDROXOCOBALAMIN 10MG/ML MDV INJ SOL, 30 ML glass vial, Red Mountain Compounding Rx.

D-0230-2020
Recall number
D-0230-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
2x30 glass 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

Lot #:S07242019DH@05, Exp 10/24/19

Distribution pattern

Nationwide in the USA

drug · product 34 of 100

S-HYDROXYPROG CAPROATE 250MG/ML IN SESAME OIL INJ, 5ML glass vial, Red Mountain Compounding Rx

D-0231-2020
Recall number
D-0231-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x5 ml 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

Lot #: S06192019DT@09, Exp 9/19/19;

Distribution pattern

Nationwide in the USA

drug · product 35 of 100

S-LEVOCARNITINE 100MG/ML MDV INJ SOLN, 30ML vial, Red Mountain Compounding Rx

D-0232-2020
Recall number
D-0232-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x30 ml 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

Lot #: S05162019DH@10, Exp 8/16/19

Distribution pattern

Nationwide in the USA

drug · product 36 of 100

S-LIDOCAINE HCL 2% INHALATION SOLN SYRINGES, 2ML syringe, Red Mountain Compounding Rx

D-0233-2020
Recall number
D-0233-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x2ML syringe

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

Lot #: S06242019DH@04, Exp 9/24/19

Distribution pattern

Nationwide in the USA

drug · product 37 of 100

S-LIDOCAINE HCL 1% MDV SOLN, 50ML Vial, Red Mountain Compounding Rx

D-0234-2020
Recall number
D-0234-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
13x50 ml 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

Lot #: S06112019DH@16, Exp 9/11/19; S06182019DT@02, Exp 9/18/19; S06182019DH@33, Exp 9/18/19; S06252019DT@08, Exp 9/25/19; S08022019DH@01, Exp 11/2/19;

Distribution pattern

Nationwide in the USA

drug · product 38 of 100

S-LIDOCAINE HCL 1% / PHENYLEPHRINE1.5% (PF) INJ SOLN, 1ml syringe, Red Mountain Compounding Rx

D-0235-2020
Recall number
D-0235-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
3x1 ml syringe

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

Lot #: S06192019DT@02, Exp 8/19/19; S06262019DT@11, Exp 8/26/19; S07312019DH@06, Exp 9/31/19

Distribution pattern

Nationwide in the USA

drug · product 39 of 100

S-LYSINE HCL 100MG/ML MDV, 30ML vial, Red Mountain Compounding Rx

D-0236-2020
Recall number
D-0236-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x30 ML 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

Lot #: S07292019DH@06, Exp 8/12/19

Distribution pattern

Nationwide in the USA

drug · product 40 of 100

S-MAGNESIUM CHLORIDE 200MG/ML MDV INJ, 30 ml vial, Red Mountain Compounding Rx

D-0237-2020
Recall number
D-0237-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

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

Lot #: S07162019DH@15, Exp 8/16/19

Distribution pattern

Nationwide in the USA

drug · product 41 of 100

S-MAGNESIUM SULFATE 500MG/ML (4MEQ/ML) MDV INJ SOLN, 30 ML vial, Red Mountain Compounding Rx

D-0238-2020
Recall number
D-0238-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
2x30 ml 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

Lot #: S06192019DT@04, Exp 9/19/19

Distribution pattern

Nationwide in the USA

drug · product 42 of 100

S-MANGANESE CHLORIDE 0.1MG/ML MDV SOLN, 10 ML vial, Red Mountain Compounding Rx

D-0239-2020
Recall number
D-0239-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
2x10 ml 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

Lot #: S05082019DT@01, Exp 9/8/19; S05222019DH@03, Exp 9/22/19

Distribution pattern

Nationwide in the USA

drug · product 43 of 100

S-METHYLCOBALAMIN 1,000MCG/ML MDV INJ; a) 10ml, b) 30 ml glass vial, Rx Only, Red mountain Compounding RX

D-0240-2020
Recall number
D-0240-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
60x 10 and 30 ML glass 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

Lot #: a) S05162019DH@10, EXP 08/16/2019,S05242019DT@07, EXP 8/24/19, S07182019DT@14 EXP 10/18/19, b) S05162019DH@18, Exp 8/16/19;S07102019DT@04, EXP 10/10/19,S07262019DH@10 EXP 10/26/19, S07292019DH@10 EXP 10/29/19

Distribution pattern

Nationwide in the USA

drug · product 44 of 100

S-MIC 25/50/50MG/ML MDV SOLN, 30ml glass vial, Rx Only, Red Mountain Compounding RX.

D-0241-2020
Recall number
D-0241-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
24x30 ml 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

Lot #: S02142019DH@01, Exp 8/14/19; S03112019DT@04, Exp 09/11/2019, S03192019DT@04, Exp 9/19/19; S04162019DT@15, Exp 10/16/19; S07172019DT@10, Exp 1/17/20; S07232019DH@04, Exp 1/23/20;

Distribution pattern

Nationwide in the USA

drug · product 45 of 100

S-NANDROLONE DEC 200MG/ML MDV INJ in SESAME OIL, Rx Only, 10ml glass vial. Red Mountain Compounding Rx.

D-0242-2020
Recall number
D-0242-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x10ml glass 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

Lot #: S07022019DT@02, Exp 10/2/19

Distribution pattern

Nationwide in the USA

drug · product 46 of 100

S-PHENOL 6% INJ SOLN, Rx Only 10ml glass vial, Red Mountain Compounding Rx.

D-0243-2020
Recall number
D-0243-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
3x10 ml glass 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

Lot #: S06242019DH@08, Exp 9/24/19; S07242019DH@08, Exp 10/24/19; S07312019DH@03, Exp 10/31/19

Distribution pattern

Nationwide in the USA

drug · product 47 of 100

S-POTASSIUM CHLORIDE 2 MEQ/ML INJECTION CONC (PF) 5ml glass vial, Rx Only Red Mountain Compounding Rx.

D-0244-2020
Recall number
D-0244-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x5ml glass 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

Lot #: S07092019DT@08, Exp 8/9/19

Distribution pattern

Nationwide in the USA

drug · product 48 of 100

S-PROCAINE HCL 1% BUFFERED MDV; Rx Only, 30ml glass vial Red Mountain Compounding Rx.

D-0245-2020
Recall number
D-0245-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x30 ml glass 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

Lot #: S0726209DH@07, Exp 10/26/19

Distribution pattern

Nationwide in the USA

drug · product 49 of 100

S-PROGESTERONE/TESTOSTERONE 0.05%/0.03% OIL OPTH, Rx Only 10ml dropper bottle, Red Mountain Compounding Rx.

D-0246-2020
Recall number
D-0246-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x10ml droptainer

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

Lot #: S05232019DT@13, Exp 8/23/19

Distribution pattern

Nationwide in the USA

drug · product 50 of 100

S-PYRIDOXINE HCL (B6) 100MG/ML MDV, Rx Only, 30ml glass vial. Red Mountain Compounding Rx.

D-0247-2020
Recall number
D-0247-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
38x30 ml glass 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

Lot #: S03072019DH@10, Exp 9/7/19; S04162019DT@18, Exp 10/16/19; S05162019DH@09, Exp 11/16/19; S05232019DT@11, Exp 11/23/19; s06182019dh@31, Exp 12/18/19; S06242019DH@14, Exp 12/24/19; S07172019DT@08, Exp 1/17/20; S07232019DH@16, Exp 1/23/20; S06242019DH@14, Exp 12/24/19

Distribution pattern

Nationwide in the USA

drug · product 51 of 100

S-QUADMIX (30MG/2MG/20MCG/0.15MG/ML) MDV INJ, Rx Only, 5ml Glass vial. Red Mountain Compounding Rx.

D-0248-2020
Recall number
D-0248-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
2x5ml Glass 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

Lot #: S06302019DH@03, Exp 8/30/19

Distribution pattern

Nationwide in the USA

drug · product 52 of 100

S-SOD CITRATE 4% INJ SOLN MDV, 10 ML glass vial, Red Mountain Compounding Rx

D-0249-2020
Recall number
D-0249-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
3x10 ml glass 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

Lot #: S07102019DT@12, Exp 8/10/19

Distribution pattern

Nationwide in the USA

drug · product 53 of 100

S-SODIUM SELINITE 0.219% INJ, 19ml glass vials, Rx only, Red Mountain Compounding Rx

D-0250-2020
Recall number
D-0250-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
11x10 ml glass 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

Lot #: S03062019JL@11, Exp 9/6/19; S04282019DH@05, Exp 10/28/19; S06182019DT@04, Exp 12/18/19; S06242019DH@11, Exp 12/24/19; " S07232019DH@15, Exp 1/23/20

Distribution pattern

Nationwide in the USA

drug · product 54 of 100

S-TAURINE 50MG/ML MDV SOLN, Rx only 30ml glass vial, Red Mountain Compounding Rx

D-0251-2020
Recall number
D-0251-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
3x30 ml glass 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

Lot #: S07232019DH@12, Exp 11/23/19; S07292019DH@05, Exp 11/29/19

Distribution pattern

Nationwide in the USA

drug · product 55 of 100

S-TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10ml glass vials, Red Mountain Compounding Rx

D-0252-2020
Recall number
D-0252-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
13x5 and 10 ml glass 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

Lot #:a) S02132019DT@02, Exp 8/13/19; b) S04092019DT@05, Exp 10/9/19; S06122019DH@35, Exp 12/12/19; S06172019DH@04, Exp 12/17/19;

Distribution pattern

Nationwide in the USA

drug · product 56 of 100

S-TESTOSTERONE HALF ULTRA 125MG/ML MDV IN SESAME OIL (TEST CYP 100MG/TEST PROP 12.5MG/NANDROLONE DECA 12.5), Rx Only, 5ML glass vial. Red Mountain Compounding Rx.

D-0253-2020
Recall number
D-0253-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x5ml glass 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

Lot #: S05302019DT@03Exp 08/30/2019,

Distribution pattern

Nationwide in the USA

drug · product 57 of 100

S-TRIMIX (15MG/0.5MG/10MCG/ML) INJ, Rx Only, 5ml glass vial, Red Mountain Compounding Rx.

D-0254-2020
Recall number
D-0254-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x5ml glass 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

Lot #: S06142019DH@01, Exp 8/14/19;

Distribution pattern

Nationwide in the USA

drug · product 58 of 100

S-VIT B COMPLEX (1/3/5/6/12A) MDV INJ 100/2/2/100/1MG/ML, 30 ML glass vial. Red Mountain Compounding Rx

D-0255-2020
Recall number
D-0255-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
2x30 ml glass 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

Lot #: S07232019DH@08 Exp 10/23/19

Distribution pattern

Nationwide in the USA

drug · product 59 of 100

S-VIT A PALMITATE 50,000 IU/ML CORN OIL, Rx Only, 10ml dropper bottle. Red Mountain Compounding Rx.

D-0256-2020
Recall number
D-0256-2020
Initiated
August 12, 2019
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

Lot #: S07292019DH@16, Exp 10/29/19

Distribution pattern

Nationwide in the USA

drug · product 60 of 100

S-VITAMIN D3 10,000 IU/ML OIL MDV INJ, Rx Only, a) 5ml b) 10 ML glass vial. Red Mountain Compounding Rx.

D-0257-2020
Recall number
D-0257-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
16x5 and 10 ml glass 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

Lot #: S04092019DT@16, Exp 8/9/19; S05012019DT@08, Exp 9/1/19; S05152019DT@01, Exp 9/15/19; S06112019DH@18, Exp 10/11/19; S06122019DT@06, Exp 10/12/19; S06192019DT@10, Exp 10/19/19; s07092019dt@16, Exp 11/9/19; S07242019DH@10, Exp 11/24/19

Distribution pattern

Nationwide in the USA

drug · product 61 of 100

S-ZINC SULFATE !MG/ML MDV SOLN, Rx only, 10ml glass vial. Red Mountain Compounding Rx.

D-0258-2020
Recall number
D-0258-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
22x10 ml glass 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

Lot # S06112019DH@13, Exp 9/11/19; S06162019DH@03, Exp 9/16/19; S06182019DH@08, Exp 9/18/19; S06242019DH@12, Exp 9/24/19; S07162019DT@10, Exp 10/16/19

Distribution pattern

Nationwide in the USA

drug · product 62 of 100

S-CALCIUM GLUCONATE 1% OPTH IRRIGATION, 50ML plastic container, RX Only, Red Mountain Compounding RX

D-0259-2020
Recall number
D-0259-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x50 ml plastic container

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

Lot #: S07162019DT@05 exp: 8/14/2019

Distribution pattern

Nationwide in the USA

drug · product 63 of 100

S-DMSO 6.25% OPTH SOLN, 10 ml dropper bottle, Rx Only, Red Mountain Compounding Rx

D-0260-2020
Recall number
D-0260-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
7x10 ml 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

Code information

Lot #:S05082019ST@05, Exp 8/8/19; S05212019DT@08, Exp 8/21/19; S05312019DT@10, Exp 8/31/19; S06272019DT@03, Exp 9/27/19; S07222019DH@06, Exp 10/22/19

Distribution pattern

Nationwide in the USA

drug · product 64 of 100

S-EDETATE DISODIUM 15% INJ, packaged in 50ml glass vial, Rx Only, Red Mountain Compounding RX.

D-0261-2020
Recall number
D-0261-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
10 50 ml 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

Lot #:S07232019DH@14 Exp 8/23/19; S07162019DT@06 Exp 8/16/19; S07172019DT@04 Exp 8/17/19

Distribution pattern

Nationwide in the USA

drug · product 65 of 100

S-ESTRADIOL CYP 5MG/ML MDV INJ IN SESAME OIL, packaged in a) 5ml, b) 10ml, c) 11ml, glass vials, Rx Only, Red Mountain Compounding RX.

D-0262-2020
Recall number
D-0262-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x5ml, 7x10ml, 3x11ml, glass 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

Lot #:S05092019DH@07, Exp 8/9/19; S05082019DT@11, Exp 8/8/19; S07032019DT@13, Exp 10/3/19; S07092019DT@09, Exp 10/9/19; S07292019DH@03, Exp 10/29/19

Distribution pattern

Nationwide in the USA

drug · product 66 of 100

S-ESTRADIOL VALERATE 40MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX.

D-0263-2020
Recall number
D-0263-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
2 5ml and 10 ml glass 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

Lot# S06062019DH@03, Exp 9/6/19; S06182019DH@01, Exp 9/18/19

Distribution pattern

Nationwide in the USA

drug · product 67 of 100

S-FOLIC ACID 20MG/ML MDV INJ, packaged in a)10ml b) 30ml, glass vials, Rx Only, Red Mountain Compounding Rx.

D-0264-2020
Recall number
D-0264-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x10, 1x30 ml glass 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

Lot# S05162019DH@17, Exp 8/26/19; S07262019DH@08, Exp 10/26/19

Distribution pattern

Nationwide in the USA

drug · product 68 of 100

S-HCG 3000 U/ML MDV SOLN, 10 ML glass vials, Rx Only, Red Mountain Compounding Rx.

D-0265-2020
Recall number
D-0265-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
8x10 ML 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

Lot #: S06272019DT@07, Exp 8/27/19; S07262019DH@04, Exp 9/26/19; S07302019DH@04, Exp 9/30/19;

Distribution pattern

Nationwide in the USA

drug · product 69 of 100

S-HCG/B12A 1000U/5MG/ML MDV INJ, packaged in a) 5ML b) 10 ML glass vials, Rx Only, Red Mountain Compounding Rx.

D-0266-2020
Recall number
D-0266-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
11x 5ml and 10ml glass 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

Lot #: a) S06112019DH@10, Exp 8/11/19; b) S06112019DH@10, Exp 8/11/19, S06142019DH@03, Exp 8/14/19, S06252019DH@14, Exp 8/25/19, S07222019DH@02, Exp 9/22/19,

Distribution pattern

Nationwide in the USA

drug · product 70 of 100

S-HYDROXOCOBA 5000MCG/ML INJ, 30ML glass vial, Red Mountain Compounding Rx

D-0267-2020
Recall number
D-0267-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x30 Ml glass 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

Lot#: S05232019DT@01, Exp 8/23/19;

Distribution pattern

Nationwide in the USA

drug · product 71 of 100

S-HYDROXOCOBALAMIN 1000MCG/ML MDV INJ; packaged in a) 10ML b) 30ML glass vial, Red Mountain Compounding Rx

D-0268-2020
Recall number
D-0268-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

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

Lot #:a) S07162019DT@04, Exp 10/16/19; b) S07162019DT@04 Exp 10/16/19

Distribution pattern

Nationwide in the USA

drug · product 72 of 100

S-HYDROXYPROG CAPROATE 250MG/ML OIL INJ, packaged in a) 5ML b) 10ML glass vial, Red Mountain Compounding Rx

D-0269-2020
Recall number
D-0269-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
16 5ml and 10ml glass 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

Lot #:a) S06242019DH@07; 9/24/19 b) S07222019DH@09, Exp 10/22/19; S05292019DT@06, Exp 8/29/19; S06032019DT@08, Exp 9/3/19; S06242019DH@07; 9/24/19

Distribution pattern

Nationwide in the USA

drug · product 73 of 100

S-LIDOCAINE HCL 2% MDV INJ SOLN, packaged in 50ML vial, Red Mountain Compounding Rx,

D-0270-2020
Recall number
D-0270-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
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

Lot #:S07092019DT@20, Exp 10/9/19; S07242019DH@08, Exp 10/24/19

Distribution pattern

Nationwide in the USA

drug · product 74 of 100

S-METHYLCOBALAMIN 10,000MCG/ML MDV INJ; 30ML glass vial, Rx Only, Red Mountain Compounding Rx

D-0271-2020
Recall number
D-0271-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
135x30 ml glass 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

Lot #: S05162019DH@12, Exp 8/16/19; S05282019DT@06, Exp 8/28/19; S05302019DT@05, Exp 8/30/19; S06182019DT@03, Exp 9/18/19; S07102019dt@05, Exp 10/10/19; S07162019DT@08, Exp 10/16/19; S07242019DH@02, Exp 10/24/19; S07252019DH@08, Exp 10/25/19; S06242019DH@01, Exp 9/24/19; S07032019DT@10, EXP 10/03/2019, S07102019DT@05, Exp 10/10/2019, 07242019DH@02, Exp 10/24/19; S07252019DH@08, Exp 10/25/2019, S07292019DH@15, Exp 10/29/19;

Distribution pattern

Nationwide in the USA

drug · product 75 of 100

S-METHYLCOBALAMIN 25MG/ML MDV INJ; 10ML glass vial, Rx Only, Red Mountain Compounding RX

D-0272-2020
Recall number
D-0272-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
2x30 ml glass 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

Lot #:S05082019DT@16, Exp 8/8/19, S06052019DT@07, Exp 9/5/19;

Distribution pattern

Nationwide in the USA

drug · product 76 of 100

S-METHYLCOBALAMIN 5,000MCG/ML MDV Injection, 30 ML glass vial, Rx Only, Red Mountain Compounding RX

D-0273-2020
Recall number
D-0273-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
28x30 ml glass 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

Lot #: S07022019DT@09, Exp 10/2/19; S05082019DT@08, Exp 8/8/19; S06042019DT@07, Exp 9/4/19

Distribution pattern

Nationwide in the USA

drug · product 77 of 100

S-MIC/B12(C)/CARNITINE 25/50/50/1/50MG/ML MDV INJ; Lot #: S07172019DT@10, Exp 1/17/20; S02142019DH@01, Exp 8/14/19; S03192019DT@04,Exp 9/19/19; " S04162019DT@15, Exp 10/16/19; S07232019DH@04, Exp 1/23/20; S02142019DH@01, Exp 8/14/19; S04162019DT@15, Exp 9/9/19; s07092019dt@19, Exp 8/9/19; S07292019DH@09, Exp 8/29/19; S02192019DH@10, Exp 8/19/19; S03302019DT@02, Exp 9/30/19; S05062019DH@12, Exp 11/6/19; S06162019DH@13, Exp 12/16/19; S07102019DT@16, Exp 1/10/20; S07132019DT@05, Exp 1/13/20; S01302019DT@08, Exp 8/30/19; S03072019DH@01, Exp 9/7/19; S02192019DH@12, Exp 8/19/19; S03072019DH@02, Exp 9/7/19; S03272019DT@04, Exp 9/27/19; S04172019DT@03, Exp 10/17/19; S04302019DT@11, Exp 10/30/19; S05162019DH@20, Exp 11/16/19; S05292019DT@03, Exp 11/29/19; S06252019DH@17, Exp 12/25/19; S07172019DT@12, Exp 1/17/20; S07182019DT@08, Exp 1/18/20; S05242019DT@10, Exp 11/24/19 Red Mountain Compounding RX

D-0274-2020
Recall number
D-0274-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

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

Lot #: S07022019DT@09, Exp 10/2/19; S05082019DT@08, Exp 8/8/19; S06042019DT@07, Exp 9/4/19

Distribution pattern

Nationwide in the USA

drug · product 78 of 100

S-MIC 25/50/50MG/ML B12A1MG/ML MDV INJ SOLN; Rx Only, a) 10ML b) 30ML glass vial. Red Mountain Compounding RX.

D-0275-2020
Recall number
D-0275-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
108x 10 and 30 ml glass 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

Lot #: a) S03272019DT@04, Exp 09/27/2019, b) S01302019DT@08, Exp 08/30/2019, S02192019DH@10, Exp 08/19/2019, S03072019DH@01, Exp 09/07/2019, S03042019DH@02, Exp 09/07/2019, S03272019DT@04, Exp 09/27/2019, S04172019DT@03, Exp 10/17/2019, S04302019DT@11, Exp 10/30/2019, S05162019DH@20, Exp 11/16/2019, S05292019DT@03, Exp 11/29/2019, S06252019DH@17, Exp 12/25/2019, S07172019DT@12, Exp 01/17/2020, S07182019DT@08, Exp 01/18/2020,

Distribution pattern

Nationwide in the USA

drug · product 79 of 100

S-MIC 25/50/50 B12A 5MG/ML MDV SOLN; Rx Only, 30ml Glass vial, Red Mountain Compounding Rx.

D-0276-2020
Recall number
D-0276-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
7x30 ml glass 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

Lot #: S03302019DT@02, Exp 09/30/2019, S05062019DH@12, Exp 11/06/2019, S06162019DH@13, Exp 12/16/2019, S07132019DT@05, Exp 01/13/2020,

Distribution pattern

Nationwide in the USA

drug · product 80 of 100

S-MIC 25/50/50MG/ML CYANO 1MG/ML MDV SOLN, RX Only, 30ml glass vial, Red Mountain Compounding Rx.

D-0277-2020
Recall number
D-0277-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x30 ml glass 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

Lot #: S05242019DT@10, Exp 08/31/2019,

Distribution pattern

Nationwide in the USA

drug · product 81 of 100

S-MICB12C/Cartinine 25/50/50/1/50MG/ML MDV INJ, Rx Only, 30ml, Red Mountain Compounding Rx.

D-0278-2020
Recall number
D-0278-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
2x30ml glass 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

Lot #: S07092019DT@19, Exp 08/09/2019, S07292019DH@09, Exp 08/29/2019,

Distribution pattern

Nationwide in the USA

drug · product 82 of 100

S-PROCAINE HCL 2% BUFFERED, Rx Only, a) PFV-single dose 10ml b)MDV 30ml glass vial, Red Mountain Compounding Rx

D-0279-2020
Recall number
D-0279-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

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

Lot #:a) S04162019DH@04, Exp 8/16/19;S04182019DT@11, Exp 8/18/19; S04302019DT@08, Exp 8/30/19; S05292019DT@11, Exp 9/29/19; S06092019DH@08, Exp 10/9/19, S06252019DH@15, Exp 10/25/19; S07022019DH@10, Exp 11/2/19, S07292019DH@11, Exp 11/29/19; b) S06032019DT@02, Exp 10/3/19; S07232019DH@03, Exp 11/23/19

Distribution pattern

Nationwide in the USA

drug · product 83 of 100

S-TESTOSTERONE CYP 100MG/ML in SESAME OIL, 5ml Rx only, Red Mountain Compounding Rx.

D-0280-2020
Recall number
D-0280-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x5ml glass 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

Lot #: S05292019dt@01, Exp 8/29/19;

Distribution pattern

Nationwide in the USA

drug · product 84 of 100

S-TEST CYP 125MG/ML MDV IN ETHYL OLEATE OIL, Rx Only, 10ml glass vial, Red Mountain Compounding Rx.

D-0281-2020
Recall number
D-0281-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
2x10ml glass 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

Lot #: S03152019JL@03, Exp 9/15/19;

Distribution pattern

Nationwide in the USA

drug · product 85 of 100

S-TEST CYP 25MG/ML IN ETHYL OLEATE OIL MDV, Rx Only, a)5 ml b) 10 ml c) 13 ml glass vial, Red Mountain Compounding Rx.

D-0282-2020
Recall number
D-0282-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
91 x 5, 10, 13 ML glass 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

Lot #: S02192019DH@14, Exp 8/19/19; S02282019DH@06, Exp 8/28/19; S03142019DT@04, Exp 9/14/19; S03252019DH@03, Exp 9/25/19; S04102019DT@05, Exp 10/10/19; S05012019DT@03, Exp 11/1/19; S05022019DT@11, Exp 11/2/19; s05012019dt@09, Exp 11/2/19; S5212019DH@14, Exp 11/21/19; S06032019DT@07, Exp 12/3/19; S06122019DT@08, Exp 12/12/19; S07162019DT@13, Exp 1/16/20; S07262019DH@05, Exp 1/26/20; S05212019DH@14, Exp 8/21/19;

Distribution pattern

Nationwide in the USA

drug · product 86 of 100

S-TEST CYP 25MG/ML IN SESAME OIL, Rx Only, 5ml glass vial, Red Mountain Compounding Rx

D-0283-2020
Recall number
D-0283-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x5 ml glass 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

Lot #: S07162019DT@12, Exp 1/16/20;

Distribution pattern

Nationwide in the USA

drug · product 87 of 100

S-TEST CYP 50MG/ML MDV IN ETHYL OLEATE OIL, Rx Only, 5ml glass vial, Red Mountain Compounding Rx

D-0284-2020
Recall number
D-0284-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x5ml glass 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

Lot #: S06162019DH@02, Exp 9/16/19;

Distribution pattern

Nationwide in the USA

drug · product 88 of 100

S-TEST CYP 200MG/ML MDV IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10 ml, c) 13ml glass vials, Red Mountain Compounding Rx.

D-0285-2020
Recall number
D-0285-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
559 x 5, 10, 13 ml glass 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

Lot #: S02072019DT@08, EXP 9/7/19; S02132019DH@06, Exp 8/13/19; S02232019DH@06 Exp 8/23/19; S02282019DH@07 Exp 8/28/19; S02252019DH@01 Exp 8/25/19; S02122019DH@06 Exp 8/12/19; S03132019DT@02 Exp 9/13/19;03202019DT@01 Exp 9/20/19; S03282019DT@05 Exp 9/28/19 S03212019DT@01 Exp 9/21/19 S04202019DT@03 Exp 10/20/19 S0412019DT@03 Exp 10/10/19 S04102019DT@12 Exp 10/10/19 S04232019DT@02 Exp 10/23/19 S03132019DT@03 Exp 9/13/19 S04232019DT@05 Exp 10/23/19 S05072019DT@07 Exp 11/7/19 S05242019DT@04 Exp 11/24/19 S06032019DT@06 Exp 12/3/19 S06182019DH@23 Exp 12/18/19 S06182019DH@22 Exp 12/18/19; S06252019DH@15, Exp 12/25/19 S06182019DH@24 Exp 12/18/19 S06262019DH@15 Exp 12/26/19 S07032019DT@03 Exp 1/3/20 S07132019DH@02 Exp 1/13/20 S07232019DH@11 Exp /23/20 S07182019DT@09 Exp 1/18/20 S07292019DH@02 Exp 1/29/20 S07312019DH@10 Exp 1/31/20 S05072019DT@07 Exp, 9/30/19 S06182019DH@23 Exp,11/30/19

Distribution pattern

Nationwide in the USA

drug · product 89 of 100

S-TESTOSTERONE CYP 200MG/ML MDV In SESAME OIL, Rx Only, a) 5ML, b) 10ML, c) 13 ML glass vial, Red Mountain Compounding Rx

D-0286-2020
Recall number
D-0286-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
129x 5ml, 10ml, 13ml glass 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

Lot #: S02252019DH@07, Exp 8/25/19; S03202019DT@02, EXP, 8/25/19; S03212019DT@02, EXP, 9/21/19; S04232019DT@06, EXP, 10/23/19; S05232019DT@06, EXP, 11/23/19; S05152019DH@12, EXP, 11/15/19; S05242019DT@03, EXP, 11/24/19; 05152019DH@12, EXP, 11/15/19; S06262019DT@02, EXP, 12/26/19; S07032019DT@12, EXP, 1/3/20; S07132019DT@03, EXP, 1/13/20; S07162019DT@01, EXP, 1/16/20; S07262019DH@06, EXP, 1/26/20; S05152019DH@12, EXP, 11/15/19;

Distribution pattern

Nationwide in the USA

drug · product 90 of 100

S-TEST CYP/NAN-DECA 200/50MG/ML MDV IN SESAME OIL; Rx Only, 10ml glass vial. Red Mountain Compounding Rx

D-0287-2020
Recall number
D-0287-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
3x10 ml glass 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

Lot #: S07162019DH@08, Exp 10/16/19; S05092019DH@05, Exp 8/9/19;

Distribution pattern

Nationwide in the USA

drug · product 91 of 100

S-TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE; Rx Only, a) 10ml b) 13ml glass vials. Red Mountain Compounding Rx.

D-0288-2020
Recall number
D-0288-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
4x 10ml and 13 ml glass 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

Lot #: a) S05212019DH@13, Exp 8/21/19; S06302019DH@07, Exp 9/30/19; S07252019DH@10, Exp 10/25/19; b) S05092019DH@05, Exp 8/9/19;

Distribution pattern

Nationwide in the USA

drug · product 92 of 100

S-TEST CYP/PROP/DECA-NAN 250MG/ML (80/10/10) IN SESAME OIL, Rx only, Rx Only, 10ml glass vial. Red Mountain Compounding Rx.

D-0289-2020
Recall number
D-0289-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x10 ml glass 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

Lot #: S06242019DH@06, Exp 9/24/2019;

Distribution pattern

Nationwide in the USA

drug · product 93 of 100

S-TEST CYP/PROP 160/40MG/ML MDV IN SESAME OIL; Rx Only, a) 10ml b) 13 ml glass vials, Red Mountain Compounding Rx.

D-0290-2020
Recall number
D-0290-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
3x 10ml and 13 ml glass 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

Lot #:a) S06182019DH@03, Exp 9/18/19; S07292019DH@04, Exp 10/29/19; b) S07092019DT@12, Exp 10/9/19;

Distribution pattern

Nationwide in the USA

drug · product 94 of 100

S-TESTOSTERONE PROPIONATE 100MG/ML MDV IN SESAME OIL, Rx Only, 5ML glass vial, Red Mountain Compounding Rx.

D-0291-2020
Recall number
D-0291-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
2x10 ml glass 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

Lot #:S04222019DH@03 Exp 10/22/2019, S06162019DH@05, Exp 12/16/2019

Distribution pattern

Nationwide in the USA

drug · product 95 of 100

S-TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL (TEST CYP 200MG/TEST PROP 25MG/NANDROLONE DECA 25MG) Rx Only, 10ml glass vial Red Mountain Compounding Rx.

D-0292-2020
Recall number
D-0292-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
10x10 ml glass 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

Lot #:S07132019DT@01, Exp 10/13/19;S07312019DH@05, Exp 10/31/19 S06122019DT@09, Exp 9/12/19;

Distribution pattern

Nationwide in the USA

drug · product 96 of 100

S-VIT B COMPLEX INJ SOLN (HP); Rx Only, 30ML glass vial, Red Mountain Compounding Rx

D-0293-2020
Recall number
D-0293-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
46 x30 ML glass 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

Lot #:S04102019DT@09, Exp 8/10/19; S05012019DT@03, Exp 9/1/19; S05162019DH@21, Exp 9/16/19; S05152019DH@21,Exp 9/16/19; S06162019DH@14, Exp 10/16/19; S06262019DT@03, Exp 10/26/19; S06262019DT@10, Exp 10/26/19; S07252019DH@11, Exp 11/25/19

Distribution pattern

Nationwide in the USA

drug · product 97 of 100

S-TRIMIX (15MG/0.5MG/16MCG/ML) INJ, Rx Only, 5ML glass vial. Red Mountain Compounding Rx.

D-0294-2020
Recall number
D-0294-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x5ml glass 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

Lot #: S05162019DT@04, Exp 8/16/19;

Distribution pattern

Nationwide in the USA

drug · product 98 of 100

S-TRIMIX (40MG/2.5MG/29MCG) MDV INJ; Rx Only, 5ml glass vial, Red Mountain Compounding Rx

D-0295-2020
Recall number
D-0295-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
1x5 ml glass 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

Lot #:S06092019DH@04, Exp 8/9/19;

Distribution pattern

Nationwide in the USA

drug · product 99 of 100

S-TRIMIX (29.4MG/0.98MG/9.8MCG/ML) INJ; Rx Only, 5ml glass vial. Red Mountain Compounding Rx

D-0296-2020
Recall number
D-0296-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
3x5ml glass 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

Lot #:S06092019DH@07, Exp 8/9/19; S06112019DH@03, Exp 8/11/19;S06122019DH@01, Exp 8/12/19;

Distribution pattern

Nationwide in the USA

drug · product 100 of 100

S-TRIMIX various strengths to include:a) S-TRIMIX (15MG/1MG/10MCG/ML) MDV: b) S-TRIMIX (18MG/0.6MG/6MCG/ML) MDV INJ: c) S-TRIMIX (24MG/0.89MG/8.9MCG/ML) MDV INJ: d) S-TRIMIX (28.85MG/1.9MG/19.2MCG/ML) MDV: e) S-TRIMIX (30MG/1MG/10MCG/ML) MDV: f) S-TRIMIX (30MG/2MG/25MCG/ML) MDV: g) S-TRIMIX (40MG/3MG/39MCG/ML) MDV INJ: h) S-TRIMIX (PA 60MG/PH 1.25MG/PG 6MCG/ML) MDV INJ: i) S-TRIMIX HYOCTANE (29.4MG/1MG/9MCG/ML) j) S-TRIMIX III (29.4MG/0.98MG/9.8MCG/ML) INJ: k) S-TRIMIX STD (16.67MG/0.58MG/8.88MCG/ML) INJ: l) S-TRIMIX-104 (30MG/2MG/20MCG/ML) MDV: m) S-TRIMIX-DS (16.67MG/0.58MG/17.7MCG/ML) MDV: Rx Only, 5ml glass vial. Red Mountain Compounding Rx

D-0297-2020
Recall number
D-0297-2020
Initiated
August 12, 2019
Classification
Class II
Status
Terminated
Quantity
34x5ml glass 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

Lot #:a) S07162019DH@07, EXP. 9/16/19 b) S06242019DH@01, EXP 8/24/19; S07102019DT@15, EXP. 9/20/19; S07252019DH@03, EXP. 9/25/19; S07312019DH@13, EXP. 9/31/19 c) S07102019DT@03, EXP. 9/10/19 d) S07262019DH@01, EXP. 9/26/19; S07232019DH@07, EXP. 9/23/19 e) S06262019DH@05, EXP. 8/26/19; S07132019DT@06, EXP. 9/13/19 f) S06162019DH@12, EXP. 8/16/19 g) S06252019DT@06, EXP. 8/25/19; S07032019DT@04, EXP. 9/3/19; S07102019DT@02, EXP. 9/10/19; h) S07172019dt@13, EXP. 9/17/19 i) S07032019DT@01, EXP. 9/3/19 j) S06092019DH@07, EXP. 8/9/19; S06112019DH@03, EXP. 8/11/19; S06122019DT@01, EXP. 8/12/19 k) S07022019DT@05, EXP. 9/2/19; S07132019DT@04, EXP. 9/13/19 l) S07022019DT@01, EXP. 9/2/19; S07302019DH@06, EXP. 9/30/19 m) S06252019DT@07, EXP. 8/25/19; n) S07022019DT@04, EXP. 9/2/19

Distribution pattern

Nationwide in the USA