FDAFDA · Food and drugs·Recall number D-0270-2021
Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial, Rx Only, Distributed by: Areva Pharmaceuticals, Inc., Gerogetown, IN 47122, Made in India, NDC 59923-714-02.
Published March 3, 2021 · Recall initiated: November 19, 2020
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
CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint and the investigation conclusions.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Areva Pharmaceuticals Inc
- Distributor
- Nationwide in the USA
- Lot
- Lot 7S10022A, Exp Jan-21
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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