Recall Enforment Report D-1152-2018

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Pharmcore Inc., originally initiated on 08-02-2018 for the product Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 The product was recalled due to lack of assurance of sterility.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1152-201808-02-201809-05-2018Class II3351 vialsHuman Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009Lack of assurance of sterility.Terminated
D-1148-201808-02-201809-05-2018Class II864 vialsHuman Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009Lack of assurance of sterility.Terminated
D-1155-201808-02-201809-05-2018Class II599 vialsIpamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009Lack of assurance of sterility.Terminated
D-1149-201808-02-201809-05-2018Class II355 vialsHuman Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009Lack of assurance of sterility.Terminated
D-1150-201808-02-201809-05-2018Class II3070 vialsHuman Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009Lack of assurance of sterility.Terminated
D-1154-201808-02-201809-05-2018Class II1115 vialsMethylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009Lack of assurance of sterility.Terminated
D-1153-201808-02-201809-05-2018Class II6 vialsIpamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009Lack of assurance of sterility.Terminated
D-1147-201808-02-201809-05-2018Class II5718 vialsHuman Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009Lack of assurance of sterility.Terminated
D-1151-201808-02-201809-05-2018Class II2085 vialsHuman Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009Lack of assurance of sterility.Terminated