Drug product
Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0463-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 266 vials
- Official record key
drug-enforcement:D-0463-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 07102018@4 BUD: 1/6/2019; 09142018@6 BUD: 3/13/2019; 10052018@4 BUD: 4/3/2019; 11062018@1 BUD: 5/5/2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility