Drug product
Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0453-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 416 vials
- Official record key
drug-enforcement:D-0453-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 07132018@5 BUD: 1/9/2019; 07302018@32 BUD: 1/26/2019; 09182018@7 BUD: 3/17/2019; 10192018@2 BUD: 4/17/2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility