D-66447-001 Class II Terminated
FDA drug recall D-66447-001 was initiated by West-Ward Pharmaceutical Corp. on September 23, 2013 and is designated Class II. 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 l… The recall status is terminated (terminated April 5, 2016). Affected quantity: 9020 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- November 13, 2013
- Initiation Date
- September 23, 2013
- Termination Date
- April 5, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9020 vials
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.
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 Pattern
Nationwide
Code Information
Lot #: AC0020, Exp 03/14; AC0023, AC0025, Exp 08/14