Drug product
Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
D-1152-2018
Product summary
- Firm
- Pharmcore Inc.
- Event
- Event 80699
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3351 vials
- Official record key
drug-enforcement:D-1152-2018
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: HCG60122 Exp. 4/30/2019; HCG60124 Exp. 6/30/2019; HCG60121 Exp. 4/30/2019; HCG60123 Exp. 5/31/2019; HCG60120 Exp. 4/30/2019; HCG60118 Exp. 2/28/2019; HCG1115 Exp. 1/31/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility