The Recall Desk
LowFDA (Drugs)·D-0069-2023·Announced 2022-11-30

Phenytoin Sodium Injection Recalled for Missing Barcode on Vial Label

Acella Pharmaceuticals is recalling Phenytoin Sodium Injection due to missing barcodes on vial labels. The recall affects 574 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 a Class III recall involving a documentation issue—missing barcodes on vial labels. No illnesses or injuries have been reported, and the product itself is not defective.

Plain-English summary

Acella Pharmaceuticals, LLC is recalling Phenytoin Sodium Injection, USP 100 mg/2 mL (packaged in 10 × 2 mL vials per carton) due to missing barcodes on the primary vial labels. The recall was initiated following customer complaints about the missing barcode identification.

A total of 574 cartons were distributed nationwide in the United States. The affected product is Lot E025A001 with an expiration date of July 2023.

No illnesses or injuries have been reported in connection with this recall. Healthcare providers and patients with questions about affected product should contact Acella Pharmaceuticals or their pharmacy.

The recalled product

Product
PHENYTOIN SODIUM (PHENYTOIN SODIUM)
Brand
PHENYTOIN SODIUM
Manufacturer
Acella Pharmaceuticals, LLC
Category
Drug
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: E025A001 Exp. 07/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · PHENYTOIN SODIUM

Same category