Drug product
Methylprednisolone Acetate 80 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 # 1011, barcode 3 70285 10111 3.
D-0682-2017
Product summary
- Event
- Event 76951
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,352 vials
- Official record key
drug-enforcement:D-0682-2017
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: 09022, Exp 04/22/17; 10001, Exp 05/02/17; 11001, Exp 05/31/17; 11010, Exp 06/03/17; 11037, Exp 06/19/17; 11041, Exp 06/25/17.
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility