Recall: D-1437-2012

Class II - Potentially Harmful

Class IIClassification

2012-04-13Initiated

TerminatedStatus

West-ward Pharmaceutical Corp.Firm

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).

Reason

Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.

Distribution

All lots were distributed throughout the US.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.