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Recall Observatory FDA recall evidence

Drug 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).

D-1437-2012

April 13, 2012

Class II

Product summary

Firm
West-ward Pharmaceutical Corp.
Event
Event 62627
Status
Terminated
Classification
Class II
Quantity
a) 308,275 vials; b) 2,008,850 vials
Official record key
drug-enforcement:D-1437-2012

Official wording

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

Code information: Lot #s: a) 113153.1, 113154.1, 113155.1, Exp 05/13; 113248.1, Exp 07/13; b) 103196.1, 103197.1, 103197.2, 103198.1, Exp 07/12; 103317.1, 103318.1, 103319.1, 103345.1, 103345.2, Exp 11/12; 103346.1, 103347.1, 103348.1, 103349.1, 103350.1, Exp 12/12; 113030.1, 113031.1, 113032.1, 113033.1, 113034.1, 113035.1, 113036.1, Exp 01/13; 113245.1, 113246.1, 113247.1, Exp 07/13

Distribution pattern: All lots were distributed throughout the US.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter