Irinotecan Hydrochloride Injection — Class II drug recall D-0270-2021
Terminated recall by Areva Pharmaceuticals Inc, reported 2021-03-03, distributed nationwide. CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate
| Recall number | D-0270-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Areva Pharmaceuticals Inc, Georgetown, IN, United States |
| Recall initiated | 2020-11-19 |
| Classified | 2021-02-21 |
| Reported by FDA | 2021-03-03 |
| Terminated | 2022-12-28 |
| Distributed | Nationwide (US) |
| Quantity | 3,287 vials |
| Reason classes | cgmp |
| NDC | 59923-0714-02 |
| Lot numbers | 7S10022A, JAN-21 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0270-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.