Drug product
Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3277-06
D-0292-2016
Product summary
- Event
- Event 72179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55 vials
- Official record key
drug-enforcement:D-0292-2016
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 Code: 20151703@26 BUD: 9/13/2015, 20151703@26 BUD: 9/13/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility