Reported Mar 3, 2021 · Terminated
Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial, Rx Only, Distributed by: Areva…
Areva Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Areva Pharmaceuticals Inc · 7112 Areva Dr Ne · Georgetown, IN · 47122-7953
Is this the product you have?
- Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial, Rx Only
- Distributed byAreva Pharmaceuticals, Inc., Gerogetown, IN 47122, Made in India, NDC 59923-714-02
- Lot codes and dates
Lot 7S10022AExp Jan-21
- Amount recalled
- 3287 vials
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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