Drug product
Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3205-06
D-0286-2016
Product summary
- Event
- Event 72179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,843 vials
- Official record key
drug-enforcement:D-0286-2016
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: 20150204@7 BUD: 9/29/2015, 20150304@1 BUD: 9/29/2015, 20150604@23 BUD: 10/3/2015, 20150807@50 BUD: 1/4/2016, 20150906@23 BUD: 12/6/2015, 20150906@24 BUD: 12/6/2015, 20152005@42 BUD: 11/16/2015, 20152206@52 BUD: 12/19/2015, 20152406@14 BUD: 12/21/2015, 20152603@26 BUD: 9/22/2015, 20152804@20 BUD: 10/25/2015, 20152904@20 BUD: 10/26/2015, 20152907@8 BUD: 1/25/2016, 20151603@56 BUD: 9/12/2015, 20152406@30 BUD: 12/21/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility