Areva Pharmaceuticals is voluntarily recalling the below mentioned batch of Irinotecan Hydrochloride Injection USP 40mg /2mL.
Product Name: Irinotecan Hydrochloride Injection USP 40mg/2ml
Batch No: 7S10022A
Manufacturing Date: Feb 2019
Expiration Date: Jan 2021
NDC Number: 59923-714-02
This recall has been initiated as a market action based on Warning Letter manufacturer received on 09 Oct 2020, and subsequent impact assessment based on retrospective review of Out-of-specification investigations, complaint and the investigation conclusion was found to be inadequate by Food and Drug Administration. Use of this product may not have potential health hazard, however we propose voluntary product Recall of this batch to the RETAIL level. No Adverse Health Consequence. We began shipping this product on 07/08/2019.
Immediately examine your inventory and quarantine product subject to recall. In addition, if you have further distributed this product, please identify your customers, and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please check your inventory carefully, discontinue distribution and use of all products with the above-mentioned lot numbers and return any opened and unopened cartons/boxes to the following address:
Areva Pharmaceuticals Inc
7112 Areva Drive NE
Georgetown, IN 47122
If you have inventory in your system, please email firstname.lastname@example.org PRIOR TO RETURN OF PRODUCT for a copy of the Recall Stock Response Form. Completed forms may be emailed back to email@example.com or faxed to 812-951-1099.
Please note that only Irinotecan Hydrochloride Injection USP 40mg /2mL mentioned in the above table is subject to the recall. This recall should be carried out to the retail level. Your assistance and cooperation IS highly appreciated.
If you have any questions, please contact Victor Swami, Pharmacist , Director of Supply Chain Management, Areva Pharmaceuticals Inc, 7112 Areva Dr. N.E, Georgetown, Indiana 47122, or email at firstname.lastname@example.org. Hours of operation: Monday through Friday 8:00am to 5:00pm EST.
This recall is being made with the knowledge of the Food and Drug Administration. We apologize for any inconvenience this voluntary recall may cause you.