West-ward Pharmaceutical Corp.: 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.

Is my product affected?

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) NOVA

• 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 (100 mg PE per 2 mL) in 2 mL single dose vials due to the presence of particles discovered in stability samples and retain samples. The affected product was distributed throughout the US in two groups: 308,275 vials and 2,008,850 vials across multiple lot numbers with expiration dates ranging from July 2012 to July 2013.

The specific lot numbers involved in the recall are: 113153.1, 113154.1, 113155.1 (Exp 05/13); 113248.1 (Exp 07/13); 103196.1, 103197.1, 103197.2, 103198.1 (Exp 07/12); 103317.1, 103318.1, 103319.1, 103345.1, 103345.2 (Exp 11/12); 103346.1, 103347.1, 103348.1, 103349.1, 103350.1 (Exp 12/12); and 113030.1, 113031.1, 113032.1, 113033.1, 113034.1, 113035.1, 113036.1 (Exp 01/13); 113245.1, 113246.1, 113247.1 (Exp 07/13). The source document does not specify what remedy affected consumers should pursue.

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) 308,275 vials; b) 2,008,850 vials Lot/code info: Lot #s: a) 113153.1, 113154.1, 113155.1, Exp 05/13; 113248.1, Exp 07/13; b) 103196.1, 103197.1, 103197.2, 103198.1, Exp 07/12; 103317.1, 103318.1, 103319.1, 103345.1, 103345.2, Exp 11/12; 103346.1, 103347.1, 103348.1, 103349.1, 103350.1, Exp 12/12; 113030.1, 113031.1, 113032.1, 113033.1, 113034.1, 113035.1, 113036.1, Exp 01/13; 113245.1, 113246.1, 113247.1, Exp 07/13

Source

Official record: FDA (Drug enforcement) ↗

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

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All FDA (Drug enforcement) recalls