Multi event Drug Recall Enforcement Report Class II voluntary initiated by West-ward Pharmaceutical Corp., originally initiated on 04-13-2012 for the 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). The product was recalled due to presence of particulate matter: this product is being recalled due to the discovery of particles in the stability samples and retain samples.. The product was distributed in All Lots Were Distributed Throughout The Us. and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-1438-2012 | 04-13-2012 | 08-08-2012 | Class II | a) 74,960 vials; b) 911,070 vials | 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). | Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples. | Terminated |
| D-1437-2012 | 04-13-2012 | 08-08-2012 | Class II | a) 308,275 vials; b) 2,008,850 vials | 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). | Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples. | Terminated |
Recalled Products
