West-ward Pharmaceutical Corp. recalls Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x
Recalled August 8, 2012 · FDA recall D-1437-2012 · 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) 308,275 vials; b) 2,008,850 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, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x 2 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 0143-9704-25), b) West-Ward (NDC 0143-9788-25).
Manufacturer(s)
West-ward Pharmaceutical Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →