FDA Drug recall D-1437-2012
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 Vi…
- 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, 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 Vi… 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-1437-2012 |
| 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, 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
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 | 0143-9704-25 |
| 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…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 |
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-1437-2012%22
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