Areva Pharmaceuticals Recalls Irinotecan Hydrochloride Injection Due to CGMP Deviations
Areva Pharmaceuticals is recalling 3,287 vials of Irinotecan Hydrochloride Injection due to manufacturing quality deviations identified in a Warning Letter.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations and inadequate investigations, which fits the rubric for moderate severity involving quality control issues without reported immediate serious harm.
Plain-English summary
Areva Pharmaceuticals, Inc. is recalling 3,287 vials of Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial. The affected product is identified by Lot 7S10022A with an expiration date of January 2021. The product was distributed nationwide in the USA.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer received a Warning Letter from the FDA citing inadequate out-of-specification investigations and complaint investigation conclusions. This is an FDA Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions. Consumers should not use the product if they have it in their possession.
The recalled product
- 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.
- Manufacturer
- Areva Pharmaceuticals Inc
- Category
- Drug — Antineoplastic
- Affected units
- 3,287
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 7S10022A
- Exp Jan-21
Distribution
Distributed nationwide across the United States.
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