November 2020 FDA Recall Drug by Areva Pharmaceuticals Inc
D-0270-2021 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Areva Pharmaceuticals Inc on November 19, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0270-2021

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.
Initiated
11-19-2020
Reported
03-03-2021
Quantity
3287 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87363
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Areva Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-28-2022
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# Lot 7S10022A, Exp Jan-21