Multi event Drug Recall Enforcement Report Class II voluntary initiated by Hikma Pharmaceuticals USA Inc., originally initiated on 06-11-2020 for the product Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9583-01 The product was recalled due to defective container: customer complaints received of a crimp defect while removing the flip-cap during use.. 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-1309-2020 | 06-11-2020 | 06-24-2020 | Class II | 17,998 vials | Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9583-01 | Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. | Terminated |
| D-1308-2020 | 06-11-2020 | 06-24-2020 | Class II | 82,426 vials | Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9701-01 | Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. | Terminated |
Recalled Products
