Drug product
Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
D-1056-2018
Product summary
- Event
- Event 80118
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2400 100-ml vials
- Official record key
drug-enforcement:D-1056-2018
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 58436:42 Use By: 05/22/2018; 58653:42 Use By: 06/12/2018; 58773:42, 58766:42, Use By: 06/21/2018; 58766:42 Use By: 06/20/2018;
Distribution pattern: Texas
Derived failure modes
-
Sterility assurance
Lack of sterility