D-0270-2021 Class II Terminated
FDA drug recall D-0270-2021 was initiated by Areva Pharmaceuticals Inc on Nov 19, 2020 and is designated Class II. 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. The recall status is terminated (terminated Dec 28, 2022). Affected quantity: 3287 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 3, 2021
- Initiation Date
- Nov 19, 2020
- Termination Date
- Dec 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0270-2021
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026