D-0270-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 3, 2021
- Initiation Date
- November 19, 2020
- Termination Date
- December 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3287 vials
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot 7S10022A, Exp Jan-21