Drug product
HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0460-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 654 vials
- Official record key
drug-enforcement:D-0460-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 06182018@5 BUD: 12/15/2018; 07102018@5 BUD: 1/6/2018; 08212018@8 BUD: 2/17/2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility