West-ward Pharmaceutical Corp. recalls Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count
Recalled August 8, 2012 · FDA recall D-1438-2012 · West-ward Pharmaceutical
Hazard
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples. · FDA Class II
Units
a) 74,960 vials; b) 911,070 vials
Sold at
All lots were distributed throughout the US.
Description
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Product
Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count x 10 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9703-10), b) West-Ward (NDC 0143-9782-10).
Manufacturer(s)
West-ward Pharmaceutical Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →