Fosphenytoin Sodium Injection — Class II drug recall D-1429-2014
Terminated recall by Fresenius Kabi USA, LLC, reported 2014-07-16, distributed nationwide. Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in
| Recall number | D-1429-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Melrose Park, IL, United States |
| Recall initiated | 2014-05-02 |
| Classified | 2014-07-09 |
| Reported by FDA | 2014-07-16 |
| Terminated | 2016-05-24 |
| Distributed | Nationwide (US) |
| Quantity | 728,880 vials |
| Reason classes | foreign material, specification failure |
| NDC | 63323-0403, 63323-0403-01, 63323-0403-02, 63323-0403-04, 63323-0403-10 |
| Lot numbers | 02/15, 03/15, 04/14, 04/15, 05/14, 05/15, 06/14, 06/15, 07/15, 08/14, 09/14, 11/15, 12/14, 6003854, 6003855, 6003961, 6004011, 6004091, 6004092, 6004553, 6004554, 6004588, 6004589, 6005201, 6005202, 6005293, 6005294, 6005545, 6005546, 6005831, 6005832, 6005973, 6005974, 6006035, 6006036, 6006037, 6006174, 6006175, 6006176, 6006449 and 3 more |
Product
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10
Reason for recall
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
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-1429-2014. 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.