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).
Reported: August 8, 2012 Initiated: April 13, 2012 #D-1438-2012
Product Description
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.
Details
- Recalling Firm
- West-ward Pharmaceutical Corp.
- Units Affected
- a) 74,960 vials; b) 911,070 vials
- Distribution
- All lots were distributed throughout the US.
- Location
- Eatontown, NJ
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by West-ward Pharmaceutical Corp.. Units affected: a) 74,960 vials; b) 911,070 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 8, 2012. Severity: Moderate. Recall number: D-1438-2012.
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