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
- Affected units
- 637
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.
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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