Acella Pharmaceuticals recalls Phenytoin Sodium Injection (250 mg/5 mL) due to missing barcode on primary vial labels. This affects patients using the product for seizures. Contact the manufacturer for details.
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Acella Pharmaceuticals is recalling Phenytoin Sodium Injection vials because the primary vial label may be missing a barcode. This issue does not pose a safety risk but could cause problems with product identification and dispensing.
The missing barcode on the primary vial label can make it difficult to identify the product correctly. This may lead to errors in dispensing or tracking the medication, but it does not pose a direct safety risk to the patient.
Patients prescribed Phenytoin Sodium Injection for seizures. Those using the product without a clear label may face difficulties with proper identification and dispensing.
Check for vials labeled 'Phenytoin Sodium Injection, USP, 250 mg/5 mL' with NDC 42192-614-05, packaged in 10 vials per carton. The product is prescription-only and manufactured by Acella Pharmaceuticals.
Verify if the primary vial label has a barcode. If missing, do not use the product.
No, the missing barcode does not pose a safety risk but may cause identification issues.
Check for vials labeled 'Phenytoin Sodium Injection, USP, 250 mg/5 mL' with NDC 42192-614-05, packaged in 10 vials per carton.
Check if the primary vial label has a barcode. If missing, do not use the product.
We’ve drafted a message you can send Acella Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0070-2023 — Acella Pharmaceuticals Acella Pharmaceuticals Hello, I own a Acella Pharmaceuticals that is covered by recall D-0070-2023 from Acella Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
