Drug product
Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1200, barcode 3 70285 12003 9.
D-0686-2017
Product summary
- Event
- Event 76951
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,156 vials
- Official record key
drug-enforcement:D-0686-2017
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: 09018, Exp 04/17/17; 09023, Exp 04/22/17; 09024, Exp 04/23/17; 09027, Exp 04/25/17; 09031, Exp 04/30/17; 10005, Exp 05/06/17; 10010, Exp 05/09/17; 11022, Exp 06/10/17; 11038, Exp 06/18/17; 11044, Exp 07/04/17; 12003, Exp 07/08/17; 12010, Exp 07/12/17; 12021, Exp 07/30/17.
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility