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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; medication was sterilized with a recalled filter

Agency Publication Date: October 4, 2016
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Affected Products

Product: Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK

071222016@24 BUD 01/08/2017, 05112016@8 BUD 11/07/2016

Product: Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK

05162016@18 BUD 09/13/2016; 07052016@9 BUD 11/02/2016; 08032016@13 BUD 12/01/2016

Product: Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK

07252016@22 BUD 09/22/2016; 08102016@28 BUD 10/08/2016

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 75212
Status: Resolved
Manufacturer: The Apothecary Shoppe LLC
Manufactured In: United States
Units Affected: 3 products (419 mL total; 455 mL total volume; 247.5 mL total volume)

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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.