FDA Drug recall D-1429-2014
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manuf…
- FDA Drug
- Class II
- terminated
- Published 2014-07-16
On 2014-07-16 the FDA classified a Class II recall of Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manuf… by Fresenius Kabi Usa, citing presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1429-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-02 |
| Published | 2014-07-16 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
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
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Identifiers
| ndc | 63323-403-01 |
|---|---|
| ndc | 63323-403-02 |
| ndc | 63323-403-04 |
| ndc | 63323-403-10 |
| code_info | Lot # 6003854; 04/14 6003855; 04/14 6004011; 05/14 6003961; 05/14 6004091; 06/14 6004092; 06/14 6004553; 08/14…Lot # 6003854; 04/14 6003855; 04/14 6004011; 05/14 6003961; 05/14 6004091; 06/14 6004092; 06/14 6004553; 08/14 6004554; 08/14 6004588; 09/14 6004589; 09/14 6005201; 12/14 6005202; 12/14 6005293; 12/14 6005294; 12/14 6005545; 02/15 6005546; 02/15 6005831; 03/15 6005832; 03/15 6005973; 04/15 6005974; 04/15 6006035; 05/15 6006036; 05/15 6006037; 05/15 6006174; 05/15 6006175; 05/15 6006176; 06/15 6006449; 07/15 6006450; 07/15 6006451; 07/15 6007168; 11/15 |
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-1429-2014%22
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