Acella Pharmaceuticals, LLC recalls 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
Recalled November 30, 2022 · FDA recall D-0070-2023 · Acella Pharmaceuticals
Hazard
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode. · FDA Class III
Units
637 cartons
Sold at
Nationwide in the USA.
Description
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
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
Manufacturer(s)
Acella Pharmaceuticals, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →