Product: 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
Reason for recall: Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Recall initiated: 20221114
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated