West-ward Pharmaceutical Corp.: 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, M

Is my product affected?

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) N

• Brand FOSPHENYTOIN SODIUM

Check against the official notice below — it lists the full affected range.

What happened

West-ward Pharmaceutical Corp. is recalling Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL vials due to the discovery of particles found in stability samples and retain samples. The affected product is a prescription injectable medication distributed throughout the United States, with a total of 986,030 vials involved across multiple lot numbers with expiration dates ranging from May 2012 to November 2013.

The source document does not specify a remedy or what affected consumers should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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. Quantity: a) 74,960 vials; b) 911,070 vials Lot/code info: 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, 112304.1, Exp 10/13; 112323.1, 112324.1, 112325.1, Exp 11/13

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVA2012-04-13
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All FDA (Drug enforcement) recalls