Drug product
Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0458-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 64 vials
- Official record key
drug-enforcement:D-0458-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 10192018@4 BUD: 12/18/2019; 11132018@5 BUD: 1/12/2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility