Drug product
Testosterone cypionate, USP (250 mg/mL), 10 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2131-07
D-0281-2016
Product summary
- Event
- Event 72179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,524 vials
- Official record key
drug-enforcement:D-0281-2016
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: 20150306@41 BUD: 11/30/2015, 20150505@56 BUD: 11/1/2015, 20150605@21 BUD: 11/2/2015, 20151607@33 BUD: 1/12/2015, 20152104@9 BUD: 10/18/2015, 20152206@24 BUD: 12/19/2015, 20151404@26 BUD: 10/11/2015, 20152104@9 BUD: 10/18/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility