Drug product
Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0479-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 10ml vials
- Official record key
drug-enforcement:D-0479-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lot: 11052018@6 BUD: 12/20/2018
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility