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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot 7S10022A, Exp Jan-21
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0270-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 19, 2020
- FDA report date
- Mar 3, 2021
- Quantity
- 3287 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Areva Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0270-2021, exactly as published.
Show all FDA fields
- City
- Georgetown
- State
- IN
- Status
- Terminated
- Country
- United States
- Event ID
- 87363
- Address
- 7112 Areva Dr Ne
- Code information
- Lot 7S10022A, Exp Jan-21
- Postal code
- 47122-7953
- Report date
- Mar 3, 2021
- Product type
- Drugs
- Recall number
- D-0270-2021
- Classification
- Class II
- Recalling firm
- Areva Pharmaceuticals Inc
- Product quantity
- 3287 vials
- Termination date
- Dec 28, 2022
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 19, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 21, 2021