FDA recall D-1438-2012

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).

Reason for recall

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

Distribution

All lots were distributed throughout the US.

Key facts

Status

Terminated

Initiation date

2012-04-13

Report date

2012-08-08

Termination date

2015-01-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1438-2012