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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug

The Apothecary Shoppe LLC: Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.; Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced..

Agency Publication Date: August 6, 2015
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Affected Products

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

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

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

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

Lot Numbers:
04302015
Product: SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2829-34

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

Lot Numbers:
04142015
Product: S-methylcobalamin 25 mg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1701-19

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

Lot Numbers:
04232015
Product: SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2896-05

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

Lot Numbers:
04202015
Product: SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-10

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

Lot Numbers:
04152015
Product: SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1461-57

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

Lot Numbers:
04232015
Product: SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10

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

Product: 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

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

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

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

Lot Numbers:
04162015
Product: SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-01

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

Lot Numbers:
04082015
Product: SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2557-43

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

Lot Numbers:
03172015
Product: SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-3169-01

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

Product: 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

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

Lot Numbers:
04162015
Product: SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1563-48

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

Lot Numbers:
04202015
Product: 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

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

Lot Numbers:
03192015
Product: SIU-Tri-Mix 18/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-1540-18

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

Product: 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

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

Lot Numbers:
05202015
Product: SIU-Tri-Mix 24/1/20 Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1747-39

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

Lot Numbers:
05052015
Product: SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-2196-10

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

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

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

Product: 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

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

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

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

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

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

Lot Numbers:
05062015
Product: SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135

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

Lot Numbers:
05042015
Product: SIU-Phentolamine 5 mg/mL in Normal Saline, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135

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

Lot Numbers:
03102015
Product: SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135

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

Lot Numbers:
04222015
Product: S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135

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

Lot Numbers:
05012015

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 71618
Status: Resolved
Manufacturer: The Apothecary Shoppe LLC
Manufactured In: United States
Units Affected: 27 products (64 mL; 98 mL; 1200.4 mL; 25.3 mL; 23 mL; 32.5 mL; 20 mL; 70 mL; 378 mL; 55 mL; 2.5 mL; 10 mL; 163 mL; 5 mL; 55 mL; 2.5 mL; 555.5 mL; 10 mL; 5 mL; 67.5 mL; 75 mL; 55 mL; 113 mL; 40 mL; 10 mL; 34 mL; 750 mL)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.