Class II
Terminated
Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 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 0143-9702-01.
- Company
- West-Ward Pharmaceutical Corp.
- Recall Initiated
- September 23, 2013
- Posted
- November 13, 2013
- Recall Number
- D-66447-001
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9020 vials
- Firm Location
- Eatontown, NJ, United States
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.
Distribution
Nationwide
Lot / Code Info
Lot #: AC0020, Exp 03/14; AC0023, AC0025, Exp 08/14
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