Class II · Moderate risk
Irinotecan HCL Injection
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Irinotecan Hydrochloride Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What 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.
Affected NDC
59923-0714-02
Compare with the code on your package — it is the most precise check available.
Drug: Irinotecan
- Recalling firm
- Areva Pharmaceuticals Inc
- NDC code
- 59923-714-02
- Origin
- IN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0270-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Irinotecan recalls
See all
Class II · Moderate risk
Irinotecan HCL Injection
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Class II · Moderate risk
IRINOTECAN 250 MG /500 ml D5W IVPB
Lack of Assurance of Sterility
Class II · Moderate risk
Irinotecan Hydrochloride Injection
Superpotent Drug: High out of specification assay value results for potency.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
Superpotent Drug: High out of specification assay value results for potency.
Other failed specification recalls from 2020
All failed specification recalls
Class II · Moderate risk
Acetaminophen Injection 1
Discoloration and failed pH specifications
Class III · Low risk
NDC 64380-721-06 Tacrolimus Capsules
Failed Moisture Limits
Class II · Moderate risk
Sodium Chloride Injection
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Class II · Moderate risk
clomiPRAMINE Hydrochloride Capsules USP
Failed Tablet/Capsule Specification
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