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FDANovember 14, 2022drug

Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

What to do

FDA enforcement status: Terminated

Brands named

acella pharmaceuticalsacella

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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