Phenytoin Sodium Injection — Class III drug recall D-0069-2023
Terminated recall by Acella Pharmaceuticals, LLC, reported 2022-11-30, distributed nationwide. Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the prim
| Recall number | D-0069-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acella Pharmaceuticals, LLC, Alpharetta, GA, United States |
| Recall initiated | 2022-11-14 |
| Classified | 2022-11-23 |
| Reported by FDA | 2022-11-30 |
| Terminated | 2024-08-21 |
| Distributed | Nationwide (US) |
| Quantity | 574 cartons |
| Reason classes | labeling |
| NDC | 42192-0614, 42192-0614-02, 42192-0614-10, 42192-0614-30 |
| Lot numbers | E025A001 |
| Expiration dates | 2023-07 |
Product
Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Reason for recall
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
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-0069-2023. 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.