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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description 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.
Recall Number D-66447-001
Classification Class II
Code Info Lot #: AC0020, Exp 03/14; AC0023, AC0025, Exp 08/14
Product Distributed Qty 9020 vials
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.

Event Detail

Event Id 66447
Product Type Drugs
Status Ongoing
Recalling Firm West-Ward Pharmaceutical Corp.
City Eatontown
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-23
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide