FDAFDA · Food and drugs·Recall number D-66447-002
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.
Published November 13, 2013 · Recall initiated: September 23, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- IRINOTECAN HYDROCHLORIDE
- Manufacturer
- West-Ward Pharmaceutical Corp.
- Distributor
- Nationwide
- UPC
- 0301439701019
- Lot
- Lot #: AC0026, AC0027, Exp 10/14
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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