FDA Drug recall D-1438-2012
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…
- FDA Drug
- Class II
- terminated
- Published 2012-08-08
On 2012-08-08 the FDA classified a Class II recall of 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… by West Ward Pharmaceutical, citing presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1438-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-04-13 |
| Published | 2012-08-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | West Ward Pharmaceutical |
| Distribution | US |
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).
Reason
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Identifiers
| ndc | 0143-9788-01 |
|---|---|
| ndc | 0143-9788-25 |
| ndc | 0143-9782-01 |
| ndc | 0143-9782-10 |
| ndc | 0143-9703-10 |
| 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, 102…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1438-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.