Drug recall D-1308-2020
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 0143-9701-01
Reason for recall
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Lots and codes
Lot #: AC0231, AC0235, exp. date 08/2021; AC0237, exp. date 09/2021
Recall details
- Recalling firm
- Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ
- Quantity
- 82,426 vials
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 11, 2020
- Terminated
- June 10, 2021
Related products
- Irinotecan Hydrochloride – drug information
- NDC 0143-9702 Irinotecan Hydrochloride · Irinotecan Hydrochloride 20 mg/mL · Hikma Pharmaceuticals USA Inc.
- NDC 0143-9701 Irinotecan Hydrochloride · Irinotecan Hydrochloride 20 mg/mL · Hikma Pharmaceuticals USA Inc.