Drug product
Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3016-02
D-0241-2016
Product summary
- Event
- Event 72179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,008 vials
- Official record key
drug-enforcement:D-0241-2016
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: 20150107@27 BUD:12/28/2015; 20150704@5 BUD: 10/4/2015; 20152005@22 BUD: 11/16/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility