D-0686-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 3, 2017
- Initiation Date
- April 6, 2017
- Termination Date
- August 30, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,156 vials
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Distribution Pattern
Nationwide in the USA and Puerto Rico
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.