Drug product
Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0455-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 93 vials
- Official record key
drug-enforcement:D-0455-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 09182018@4 BUD: 3/17/2019; 10052018@3 BUD: 4/3/2019; 11132018@3 BUD: 5/12/2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility