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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71618

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

Open FDA event record

Event summary

Timeline bucket
June 26, 2015
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
The Apothecary Shoppe LLC

Dossier provenance

Source snapshots represented here

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

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

How coverage and grouping work

Complete imported group

Every recalled product in this event

28 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 28

S-Methylcobalamin 1000 mcg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1962-40

D-1289-2015
Recall number
D-1289-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
64 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #s: 03132015@28, BUD 9/9/2015; 04082015@46, BUD 10/5/2015; 04222015@5, BUD 10/19/2015

Distribution pattern

Oklahoma

drug · product 2 of 28

S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80

D-1290-2015
Recall number
D-1290-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
98 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #: 04302015@66, BUD 06/29/2015

Distribution pattern

Oklahoma

drug · product 3 of 28

SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2829-34

D-1291-2015
Recall number
D-1291-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
1200.4 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #: 04142015@5, BUD 8/12/2015; 04032015@23, BUD 7/2/2015; 04242015@28, BUD 8/22/2015

Distribution pattern

Oklahoma

drug · product 4 of 28

S-methylcobalamin 25 mg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1701-19

D-1292-2015
Recall number
D-1292-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
25.3 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #: 04232015@28, BUD 10/20/2015

Distribution pattern

Oklahoma

drug · product 5 of 28

SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2896-05

D-1293-2015
Recall number
D-1293-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
23 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #: 04202015@33, BUD 8/18/2015; 04272015@18, BUD 8/25/2015

Distribution pattern

Oklahoma

drug · product 6 of 28

SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-10

D-1294-2015
Recall number
D-1294-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
32.5 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #: 04152015@6, BUD 10/12/2015; 03102015@41, BUD 07/08/2015

Distribution pattern

Oklahoma

drug · product 7 of 28

SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1461-57

D-1295-2015
Recall number
D-1295-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
20 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced..

Code information

Lot #: 04232015@22, BUD 10/20/2015

Distribution pattern

Oklahoma

drug · product 8 of 28

SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10

D-1296-2015
Recall number
D-1296-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
70 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #s: 03102015@30, BUD 7/8/2015; 04162015@30, BUD 10/13/2015

Distribution pattern

Oklahoma

drug · product 9 of 28

SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1802-97

D-1297-2015
Recall number
D-1297-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
378 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #s: 04282015@9, BUD 10/25/2015; 04172015@15, BUD 10/14/2015; 04022015@10, BUD 9/1/2015

Distribution pattern

Oklahoma

drug · product 10 of 28

SIU-Papav/Phent 30/1 mg Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10

D-1298-2015
Recall number
D-1298-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
55 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #: 04162015@30, BUD 10/13/2015

Distribution pattern

Oklahoma

drug · product 11 of 28

SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-01

D-1299-2015
Recall number
D-1299-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
2.5 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #: 04082015@37, BUD 10/05/2015

Distribution pattern

Oklahoma

drug · product 12 of 28

SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2557-43

D-1300-2015
Recall number
D-1300-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
10 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #: 03172015@39, BUD 07/15/2015

Distribution pattern

Oklahoma

drug · product 13 of 28

SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-3169-01

D-1301-2015
Recall number
D-1301-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
163 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #s: 04172015@33, BUD 10/14/2015; 04292015@10, BUD 10/26/2015

Distribution pattern

Oklahoma

drug · product 14 of 28

SIU-Tri-Mix 17/0.6/5.7 Injectable, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2348-22

D-1302-2015
Recall number
D-1302-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
5 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #: 04162015@36, BUD 10/13/2015

Distribution pattern

Oklahoma

drug · product 15 of 28

SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1563-48

D-1303-2015
Recall number
D-1303-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
55 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #: 04202015@34, BUD 10/17/2015

Distribution pattern

Oklahoma

drug · product 16 of 28

SIU-Tri-Mix 6/0.33/3.33 Injection Solution, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2007-70

D-1304-2015
Recall number
D-1304-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
2.5 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #: 03192015@27, BUD 07/13/2015

Distribution pattern

Oklahoma

drug · product 17 of 28

SIU-Tri-Mix 18/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-1540-18

D-1305-2015
Recall number
D-1305-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
555.5 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #s: 04062015@30, BUD: 09/01/2015; 04172015@20, BUD: 10/14/2015

Distribution pattern

Oklahoma

drug · product 18 of 28

SIU-Tri-Mix 20/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2913-85

D-1306-2015
Recall number
D-1306-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
10 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #: 05202015@14, BUD 11/16/2015

Distribution pattern

Oklahoma

drug · product 19 of 28

SIU-Tri-Mix 24/1/20 Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1747-39

D-1307-2015
Recall number
D-1307-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
5 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #: 05052015@39, BUD 11/1/2015

Distribution pattern

Oklahoma

drug · product 20 of 28

SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-2196-10

D-1308-2015
Recall number
D-1308-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
67.5 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #s: 04162015@41, BUD: 10/13/2015; 03122015@42, BUD: 7/10/2015

Distribution pattern

Oklahoma

drug · product 21 of 28

SIU-Tri-Mix 30/2/20 Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1398-47

D-1309-2015
Recall number
D-1309-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
75 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #s: 04082015@45, BUD 9/1/2015; 04162015@28, BUD 10/13/2015; 03182015@9, BUD 7/16/2015

Distribution pattern

Oklahoma

drug · product 22 of 28

SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13389-1152-36

D-1310-2015
Recall number
D-1310-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
55 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #s: 05052015@11, 05052015@28, BUD 11/1/2015; 03102015@38, BUD 7/8/2015

Distribution pattern

Oklahoma

drug · product 23 of 28

SIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135,NDC 99999-2011-17

D-1311-2015
Recall number
D-1311-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
113 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #s: 04102015@38, BUD: 9/1/2015; 03132015@37, BUD: 7/11/2015; 04172015@28, BUD: 10/14/2015

Distribution pattern

Oklahoma

drug · product 24 of 28

SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94

D-1312-2015
Recall number
D-1312-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
40 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #: 05062015@28, BUD 07/05/2015

Distribution pattern

Oklahoma

drug · product 25 of 28

SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135

D-1313-2015
Recall number
D-1313-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #: 05042015@33, BUD 10/31/2015; 03102015@45, 03112015@14, 03192015@42, BUD 09/01/2015

Distribution pattern

Oklahoma

drug · product 26 of 28

SIU-Phentolamine 5 mg/mL in Normal Saline, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135

D-1314-2015
Recall number
D-1314-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
10 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #: 03102015@42, BUD 09/06/2015

Distribution pattern

Oklahoma

drug · product 27 of 28

SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135

D-1315-2015
Recall number
D-1315-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
34 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #: 04222015@20, BUD 08/30/2015

Distribution pattern

Oklahoma

drug · product 28 of 28

S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135

D-1316-2015
Recall number
D-1316-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
The Apothecary Shoppe LLC
Quantity
750 mL

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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information

Lot #: 05012015@4, BUD 10/28/2015

Distribution pattern

Oklahoma