Drug product
Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0452-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 927 vials
- Official record key
drug-enforcement:D-0452-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 07052018@1 BUD: 1/1/2019; 09182018@6 BUD: 3/1/2019; 09212018@10 BUD: 3/4/2019; 10052018@1 BUD: 3/18/2019; 11062018@2 BUD: 4/19/2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility