Drug product
Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0445-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 288 10 ml vials
- Official record key
drug-enforcement:D-0445-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 09172018@7 BUD: 12/16/2018; 10292018@2 BUD: 1/27/2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility