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…

Is this the product you have?

• 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
• ByHikma Farmaceutica (Portugal), S.A.; Dist
• ByWest-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9704-25), b) West-Ward (NDC 0143-9788-25)

Lot codes and dates

• • 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

Amount recalled

a) 308,275 vials; b) 2,008,850 vials

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

• Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single…

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.