Acella Pharmaceuticals recalls Phenytoin Sodium Injection due to missing barcode on primary vial labels. This affects specific lot numbers and packaging. Consumers should check labels and 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, 100 mg/2 mL vials, because customer complaints reported missing barcodes on the primary vial labels. This issue does not pose a safety risk but affects product identification and may cause confusion in medication management.
The missing barcode on the primary vial label prevents proper product identification. This could lead to confusion in medication management but does not cause injury or health risks.
Patients prescribed Phenytoin Sodium Injection by a healthcare provider. Those using the product without a valid barcode label may face identification issues but no safety risk.
Check for the primary vial label missing a barcode. The product is packaged in 10 x 2 mL vials per carton with NDC 42192-614-02 and lot number E025A001 (expiring 07/2023).
Look for the missing barcode on the primary vial label.
No, the missing barcode does not pose a safety risk but may cause identification issues.
Check the label for a missing barcode. If found, contact Acella Pharmaceuticals for further instructions.
The product has NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, with lot number E025A001 (expiring 07/2023).
We’ve drafted a message you can send Acella Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0069-2023 — Acella Pharmaceuticals Acella Pharmaceuticals Hello, I own a Acella Pharmaceuticals that is covered by recall D-0069-2023 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.
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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.
