FDA Drug recall D-0076-2018
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only
- FDA Drug
- Class II
- terminated
- Published 2017-11-22
On 2017-11-22 the FDA classified a Class II recall of Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only by Amneal Pharmaceuticals, citing presence of Particulate Matter.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0076-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-31 |
| Published | 2017-11-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Amneal Pharmaceuticals |
| Distribution | MS, NC, OH, TX, UT |
Product
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7
Reason
Presence of Particulate Matter
Identifiers
| code_info | Lot # AP160016; Exp. 05/18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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All Amneal Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0076-2018%22
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