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.
Reported: March 3, 2021 Initiated: November 19, 2020 #D-0270-2021
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.
Details
- Recalling Firm
- Areva Pharmaceuticals Inc
- Units Affected
- 3287 vials
- Distribution
- Nationwide in the USA
- Location
- Georgetown, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Areva Pharmaceuticals Inc. Units affected: 3287 vials.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 3, 2021. Severity: Moderate. Recall number: D-0270-2021.
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