Drug product
Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0.
D-0684-2017
Product summary
- Event
- Event 76951
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,951 vials
- Official record key
drug-enforcement:D-0684-2017
Official wording
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Code information: Lot #s: 10013, Exp 05/10/17; 10020, Exp 05/20/17; 10029, Exp 05/27/17; 11002, Exp 05/30/17; 11013, Exp 06/04/17.
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility