Unrated Drug recall · FDA · Published November 19, 2020

Areva Recalls Irinotecan Hydrochloride Injection Due to CGMP Deviations

Areva Pharmaceuticals recalls 3,287 vials of Irinotecan Hydrochloride Injection due to CGMP deviations. Check lot numbers and expiration dates for affected units.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0270-2021Drug Areva Pharmaceuticals ›

Recall notice

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.

Take action

Contact the company

Recalling firmAreva Pharmaceuticals Inc7112 Areva Dr Ne · Georgetown, IN 47122-7953

✎ GovInfoNow plain-language explainer

Areva Pharmaceuticals Inc has recalled one lot of Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL distributed nationwide in the USA. The recall is due to Current Good Manufacturing Practice (CGMP) deviations related to inadequate investigations of out-of-specification results and complaints. No specific consumer injury mechanism or remedy instructions are provided in this record. Read more at govinfonow.com/recall/36666-areva-recalls-irinotecan-hydrochloride-injection-due-to-cgmp-deviations.

Source Summary by GovInfoNow · govinfonow.com/recall/36666-areva-recalls-irinotecan-hydrochloride-injection-due-to-cgmp-deviations · Updated October 11, 2026 · FDA enforcement record: FDA #D-0270-2021

Cite this page

“Areva Recalls Irinotecan Hydrochloride Injection Due to CGMP Deviations.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/36666-areva-recalls-irinotecan-hydrochloride-injection-due-to-cgmp-deviations. Based on FDA recall #D-0270-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0270-2021%22&limit=1).

The FDA announced on Nov. 19, 2020, that Areva Pharmaceuticals Inc voluntarily recalled Irinotecan Hydrochloride Injection due to current good manufacturing practice deviations. The recall involves 3,287 vials distributed nationwide in the USA.

How to tell if you have it

Brand: Areva Pharmaceuticals
Product: Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial
NDC: 59923-714-02
Lot code: 7S10022A
Expiration date: Jan-21

The hazard

The recall was initiated based on a Warning Letter received by the manufacturer regarding inadequate investigations of out-of-specification results, complaints, and investigation conclusions.

Context

GovInfoNow's records show other recent recalls of similar products include Wells Pharma Fentanyl Citrate Injectable Solution Recall: Cgmp Deviations (2026-04-01), Nivagen Zinc Oxide Ointment Recall: Cgmp Deviations (2025-10-31), and Baxter Vasopressin Injection Recall: CGMP Deviations Risk (2026-08-06).

How to tell if you have this one

Look for Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), in a 2 mL Single-Dose Vial. The affected product is Rx Only, distributed by Areva Pharmaceuticals, Inc., made in India, with NDC 59923-714-02. Specifically check for Lot 7S10022A with an expiration date of Jan-21.

Brand
Areva Pharmaceuticals
Category
Drug

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

Nov 19, 2020Firm started the recall
Feb 21, 2021FDA classified it Class II
Mar 3, 2021Published in FDA’s Enforcement Report
Dec 28, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/36666-areva-recalls-irinotecan-hydrochloride-injection-due-to-cgmp-deviations">Areva Recalls Irinotecan Hydrochloride Injection Due to CGMP Deviations (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0270-2021 (November 19, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0270-2021 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.