Drug product
Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0449-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 255 vials
- Official record key
drug-enforcement:D-0449-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 06182018@2 BUD: 12/15/2018; 08212018@12 BUD: 2/17/2019; 09212018@15 BUD: 3/20/2019; 11132018@1 BUD: 5/12/2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility