Drug product
Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
D-1147-2018
Product summary
- Firm
- Pharmcore Inc.
- Event
- Event 80699
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5718 vials
- Official record key
drug-enforcement:D-1147-2018
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: HCG50319 Exp. 4/30/2019; HCG50316 Exp. 3/31/2019; HCG50317 Exp. 4/30/2019; HCG50315 Exp. 3/31/2019; HCG50318 Exp. 4/30/2019; HCG50320 Exp. 4/30/2019; HCG50321 Exp. 4/30/2019; HCG50311 Exp. 3/31/2019; HCG50310 Exp. 3/31/2019; HCG50309 Exp. 3/31/2019; HCG50313 Exp. 3/31/2019; HCG50314 Exp. 3/31/2019;
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility