Drug product
Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3206-01
D-0287-2016
Product summary
- Event
- Event 72179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33,778 vials
- Official record key
drug-enforcement:D-0287-2016
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: 20150608@19 BUD: 2/2/2016, 20150807@35 BUD: 1/4/2016, 20152104@12 BUD: 10/1//2015, 20150105@2 BUD: 10/28/2015, 20150605@36 BUD: 11/2/2015, 20150607@26 BUD: 1/2/2016, 20150904@32 BUD: 10/6/2015, 20150906@35 BUD: 12/6/2015, 20151506@45 BUD: 12/12/2015, 20151603@43 BUD: 9/12/2015, 20152204@15 BUD: 10/19/2015, 20152506@35 BUD: 12/22/2015, 20152907@1 BUD: 1/25/2016
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility