Argatroban Injection 50 mg/50mL
March 23, 2012
Eagle Pharmaceuticals Inc. and The Medicines Company voluntarily recalled all 4 lots of Argatroban 50mg/50 mL injection including single count vials (NDC 42367-0203-07) and 10 count vials (NDC 42367-0203-84) on December 2, 2011. Particulate matter was found in a small number of vials and may pose a safety risk if administered to patients. No adverse reactions have been reported as a result of the particulates.
The recall affects the following lot numbers:
- Lot # V10189 (expiration January 2013)
- Lot # V10191 (expiration January 2013)
- Lot # V10194 (expiration January 2013)
- Lot # V10223 (expiration February 2013)
Immediately quarantine and avoid administering affected lot numbers. Pharmacies and distributors must return affected argatroban injection presentations to TMC Direct. Do not return Argatroban to wholesalers or third party companies. Contact The Medicines Company at 1-888-977-6326 or email@example.com with questions about returning recalled product. Report adverse effects from the use of any of the recalled argatroban lots to FDA’s MedWatch program.
Additional information is available at the following link:
- MedWatch Alert:
- Voluntary Recall Notice:
- Press Release:
March 23, 2012; December 6, 2011; University of Utah, Drug Information Service. Copyright 2012 Drug Information Service, University of Utah, Salt Lake City, UT.