Drug product
Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
D-1151-2018
Product summary
- Firm
- Pharmcore Inc.
- Event
- Event 80699
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2085 vials
- Official record key
drug-enforcement:D-1151-2018
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: HCG40160 Exp. 2/28/2019; HCG40161 Exp. 4/30/2019; HCG40159 Exp. 2/28/2019; HCG40162 Exp. 4/30/2019; HCG50308 Exp. 2/28/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility