Drug product
Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-10
D-0238-2016
Product summary
- Event
- Event 72179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,494 vials
- Official record key
drug-enforcement:D-0238-2016
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: 20150104@4 BUD: 9/27/2015; 20150105@1 BUD: 10/27/2015; 20150107@25 BUD: 12/27/2015; 20150306@44 BUD: 11/29/2015; 20150704@49 BUD: 10/3/2015; 20150705@5 BUD: 11/1/2015; 20151106@17 BUD: 12/7/2015; 20151305@5 BUD: 11/8/2015; 20151806@19 BUD: 12/13/2015; 20152005@29 BUD: 11/15/2015; 20152205@7 BUD: 11/16/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility