Drug product
Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0471-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 10 ml vials
- Official record key
drug-enforcement:D-0471-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 11132018@9 BUD: 12/28/2018;
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility