Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count…

Is this the product you have?

• 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
• ByHikma Farmaceutica (Portugal), S.A.; Dist
• ByWest-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9703-10), b) West-Ward (NDC 0143-9782-10)

Lot codes and dates

• 66 of 66 codes

  • 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

  Show all 66 codes

Amount recalled

a) 74,960 vials; b) 911,070 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, 100 mg PE per 2 mL (50 mg PE per mL), 2 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.