Drug product
Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
D-1322-2019
Product summary
- Event
- Event 82941
- Status
- Terminated
- Classification
- Class II
- Quantity
- 716 vials
- Official record key
drug-enforcement:D-1322-2019
Official wording
Reason: Lack of Sterility Assurance.
Code information: Lot #: 11292018:75 Exp. 05/28/2019; 01022019:70 Exp. 07/01/2019; 02042019:04 Exp. 08/03/2019; 03042019:94 Exp. 08/31/2019
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Sterility