drugs Class II Updated 2012-08-08

West-ward Pharmaceutical Corp. recalls Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50

Recalled 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).

Hazard / Issue

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

Issued by

FDA

Distribution: All lots were distributed throughout the US.
Lot/Code Info: Lot #s: a) 112161.1, 112162.1, 112163.1, Exp 05/13; b) 102165.2, 102167.1, Exp 05/12; 102190.1, 102191.1, 102191.2, 102192.1, 102213.1, Exp 07/12; 102240.1, 102241.1, 10227.1, 102272.1, 102272.2, 102273.1, 102274.1, 102275.1, Exp 09/12; 102319.1, 102320.1, 102321.1, 102322.1, 102323.1, 102324.1, 102325.1, Exp 11/12; 102342.1, 102343.1, 102344.1, 102345.1, Exp 12/12; 112019.1, 112020.1, 112021.1, 112022.1, 112023.1, Exp 01/13; 112156.1, 112157.1, 112158.1, 112159.1, 112160.1, Exp 05/13; 112164.1, Exp 06/13; 112203.1, 112204.1, 112205.1, 112206.1, Exp 07/13; 112262.1, 112263.1, Exp 09/13; 112301.1, 112302.1, 112303.1, 112304.1, Exp 10/13; 112323.1, 112324.1, 112325.1, Exp 11/13
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