Drug product
Methylcobalamin (12.5 mg/mL), 2.5 mL Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3251-04.
D-0264-2016
Product summary
- Event
- Event 72179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 265 vials
- Official record key
drug-enforcement:D-0264-2016
Official wording
Reason: Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Code information: Lot Numbers: 20152105@38 BUD: 11/17/2015, 20152705@34 BUD: 11/23/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility