Recalls / Class II
Class IID-0002-2017
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
- Affected lot / code info
- 071222016@24 BUD 01/08/2017, 05112016@8 BUD 11/07/2016
Why it was recalled
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Recalling firm
- Firm
- The Apothecary Shoppe LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 6136 E 51st St, N/A, Tulsa, Oklahoma 74135-7704
Distribution
- Quantity
- 419 mL total
- Distribution pattern
- Oklahoma
Timeline
- Recall initiated
- 2016-09-12
- FDA classified
- 2016-10-04
- Posted by FDA
- 2016-10-12
- Terminated
- 2018-01-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0002-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.