The Recall Desk
LowFDA (Drugs)·D-0070-2023·Announced 2022-11-30

Phenytoin Sodium Injection Recalled for Missing Vial Barcode

Acella Pharmaceuticals is recalling Phenytoin Sodium Injection because the primary vial label is missing a barcode. The recall affects 637 cartons distributed nationwide.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is an FDA Class III recall involving a labeling defect (missing barcode) with no reported adverse health consequences. The hazard is administrative/documentary in nature, meeting the criteria for Low severity.

Plain-English summary

Acella Pharmaceuticals, LLC is recalling Phenytoin Sodium Injection, USP, 250 mg/5 mL (Lot E026A001, Exp. 06/2023) due to a labeling defect. The primary vial label on affected units is missing a barcode, which was reported by customers.

The recalled product was distributed nationwide in the USA. A total of 637 cartons were affected. The product is a prescription injection administered by intramuscular or intravenous route.

Healthcare providers and patients who have received this product should check their vials. If you have questions about whether your supply is affected or about obtaining replacement product, contact Acella Pharmaceuticals, LLC.

The recalled product

Product
PHENYTOIN SODIUM (PHENYTOIN SODIUM)
Brand
PHENYTOIN SODIUM
Manufacturer
Acella Pharmaceuticals, LLC
Category
Drug — Injection / Injectable
Hazard
  • mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: E026A001 Exp. 06/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · PHENYTOIN SODIUM

Same category