Drug recall D-1437-2012
Product
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) NOVAPLUS (NDC 0143-9704-25), b) West-Ward (NDC 0143-9788-25).
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.
Lots and codes
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
Recall details
- Recalling firm
- West-ward Pharmaceutical Corp., Eatontown, NJ
- Quantity
- a) 308,275 vials; b) 2,008,850 vials
- Distribution
- All lots were distributed throughout the US.
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 13, 2012
- Terminated
- January 16, 2015
Related products
- Fosphenytoin Sodium – drug information
- NDC 0143-9788 Fosphenytoin Sodium · Fosphenytoin Sodium 50 mg/mL · West-Ward Pharmaceuticals Corp
- NDC 0143-9782 Fosphenytoin Sodium · Fosphenytoin Sodium 50 mg/mL · West-Ward Pharmaceuticals Corp