Acella Pharmaceuticals, LLC recalls Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10,

Recalled November 30, 2022 · FDA recall D-0069-2023 · 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

574 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 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, 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 →