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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
- Affected units
- 574
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.
Part of a larger recall action
This product is one of 2 recalled by Acella Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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