Drug product
Testosterone EO-Pro-Cyp 220 (220 mg/mL) 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2169-06
D-0282-2016
Product summary
- Event
- Event 72179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,386 vials
- Official record key
drug-enforcement:D-0282-2016
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: 20151006@46 BUD: 12/7/2015, 20151607@40 BUD: 1/12/2016, 20152005@32 BUD: 11/16/2015, 20152304@28 BUD: 10/20/2015, 20152304@5 BUD: 10/20/2015, 20152606@2 BUD: 12/22/2015, 20152907@16 BUD: 1/23/2016
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility