CLASS II Drug recall · Reported 3 Mar 2021 · FDA Enforcement Report
Irinotecan Hydrochloride Injection, USP, 40 mg recalled
Areva Pharmaceuticals is recalling Irinotecan Hydrochloride Injection, USP, 40 mg/ (20 mg/mL) Single-Dose Vial, distributed nationwide in the US. The recall was initiated on 19 Nov 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0270-2021
- FDA event ID
- 87363
- Recalling firm
- Areva Pharmaceuticals, Georgetown, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Nov 2020
- FDA classified
- 21 Feb 2021
- Reported
- 3 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 19 Nov 2020 | Recall initiated by company | |
| 21 Feb 2021 | Classified by FDA | +94 days |
| 3 Mar 2021 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it 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 lots are affected?
Lot 7S10022A, Exp Jan-21
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Irinotecan recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Irinotecan HCL Injection, USP, 100mg/ vials recalledIrinotecan Hydrochloride | Hikma Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Irinotecan HCL Injection, USP, 100mg/ vials recalledIrinotecan Hydrochloride | Hikma Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Irinotecan 250 MG / D5w Ivpb recalled by Infusion Options | Infusion Options | Sterility | NY |
| Drug | CLASS II | Irinotecan Hydrochloride Injection, USP, 40 mg/ (20 mg/mL) recalled | Ingenus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Irinotecan Hydrochloride Injection, USP, 100 mg/ (20 mg/mL) recalled | Ingenus Pharmaceuticals | Potency & Assay | Nationwide |