FDA-Drug2012-08-08Class II
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).
West-ward Pharmaceutical Corp.
Hazard
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Sold states
All lots were distributed throughout the US.
Affected count
a) 74,960 vials; b) 911,070 vials
Manufactured in
465 Industrial Way W, N/A, Eatontown, NJ, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1438-2012Don't want to check this manually?
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