This recall involves approximately 1,211 cartons of Phenytoin Sodium Injection, USP, an anti-seizure medication distributed by Acella Pharmaceuticals, LLC. The medication is being recalled because the labels on the primary drug vials are missing a required barcode. While no injuries or adverse events have been reported, the missing barcode could lead to medication errors if a healthcare provider cannot scan the vial to verify the drug and dose before administration.
The absence of a barcode on the vial label prevents medical professionals from using automated scanning systems to verify the medication's identity and strength. This increases the risk of administering the wrong medication or incorrect dosage to a patient, which could lead to serious adverse health consequences or therapeutic failure.
Quantity: 574 cartons. Manufactured for Acella Pharmaceuticals, LLC.
Quantity: 637 cartons. Manufactured for Acella Pharmaceuticals, LLC.
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Sources: FDA iRES · Raw API Response
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