Drug product
Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
D-1149-2018
Product summary
- Firm
- Pharmcore Inc.
- Event
- Event 80699
- Status
- Terminated
- Classification
- Class II
- Quantity
- 355 vials
- Official record key
drug-enforcement:D-1149-2018
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: HCG22038 Exp. 3/31/2019; HCG22039 Exp. 4/30/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility