Fosphenytoin Sodium Injection — Class II drug recall D-1437-2012
Terminated recall by West-ward Pharmaceutical Corp., reported 2012-08-08, distributed nationwide. Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stabil
| Recall number | D-1437-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | West-ward Pharmaceutical Corp., Eatontown, NJ, United States |
| Recall initiated | 2012-04-13 |
| Classified | 2012-08-02 |
| Reported by FDA | 2012-08-08 |
| Terminated | 2015-01-16 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00143-9704-25, 00143-9782, 00143-9782-01, 00143-9782-10, 00143-9788, 00143-9788-01, 00143-9788-25 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1437-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.