Drug product
Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1020, barcode 3 70285 10201 1.
D-0683-2017
Product summary
- Event
- Event 76951
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,335 vials
- Official record key
drug-enforcement:D-0683-2017
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: 09032, Exp 04/06/17; 10017, Exp 04/19/17; 10022, Exp 04/26/17; 10031, Exp 05/04/17; 11021, Exp 05/17/17; 12007, Exp 06/16/17.
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility