Drug recall D-66447-002
Product
Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA, NDC 0143-9701-01.
Reason for recall
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
Lots and codes
Lot #: AC0026, AC0027, Exp 10/14
Recall details
- Recalling firm
- West-Ward Pharmaceutical Corp., Eatontown, NJ
- Quantity
- 9813 vials
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 23, 2013
- Terminated
- April 5, 2016
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.