FDA Drug recall D-0070-2023
Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufact…
- FDA Drug
- Class III
- terminated
- Published 2022-11-30
On 2022-11-30 the FDA classified a Class III recall of Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufact… by Acella Pharmaceuticals, citing labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0070-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-11-14 |
| Published | 2022-11-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Acella Pharmaceuticals |
| Distribution | US |
Product
Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Reason
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Identifiers
| ndc | 42192-614-10 |
|---|---|
| ndc | 42192-614-30 |
| ndc | 42192-614-05 |
| code_info | Lot: E026A001 Exp. 06/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0070-2023%22
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