Fosphenytoin Sodium Injection from Hospira- Recall
May 27, 2010
Hospira is voluntarily recalling all lots of fosphenytoin sodium 75 mg/mL (50 mg PE/mL) in 2 mL and 10 mL vials due to presence of particulate matter. The particulate matter is from an interaction of the stopper, silicon on the stopper, and raw drug material. No adverse events have been reported due to particulate matter at this time. Hospira will continue to monitor and investigate any issues that come up regarding this recall. This recall includes all lot numbers with an expiration date of June 1, 2010 to December 1, 2011 for fosphenytoin sodium 75 mg/mL vials with the following NDC numbers: 00409-4857-02, 00409-4857-10, 00409-4857-49, and 00409-4857-50. Do not use fosphenytoin from the affected lots and quarantine the product. Return product from these presentations to Stericycle (866-300-3432).
Additional information is available at the following links:
- Recall Notice:
- Recall Reply Form including list of affected lot numbers:
May 26, 2010; University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.