FDA Drug recall D-1428-2014
Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufact…
- 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, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufact… 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-1428-2014 |
| 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, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-02
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 # 6003850; 04/14 6003926; 05/14 6004052; 05/14 6004053; 05/14 6004093; 06/14 6004094; 06/14 6004199; 07/14…Lot # 6003850; 04/14 6003926; 05/14 6004052; 05/14 6004053; 05/14 6004093; 06/14 6004094; 06/14 6004199; 07/14 6004200; 07/14 6004509; 08/14 6004510; 08/14 6004661; 09/14 6005157; 11/14 6005158; 11/14 6005197; 11/14 6005198; 11/14 6005446; 01/15 6005447; 01/15 6005702; 03/15 6005703; 03/15 6005790; 03/15 6005791; 03/15 6006005; 05/15 6006006; 05/15 6006091; 05/15 6006211; 06/15 6006212; 06/15 6006396; 07/15 6006397; 07/15 |
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-1428-2014%22
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