Acella Pharmaceuticals, LLC: Drug Recall

Recall #D-0069-2023 · 11/14/2022

Class III: Low Risk

Recall Details

Recall Number
D-0069-2023
Classification
Class III
Product Type
Drug
Recalling Firm
Acella Pharmaceuticals, LLC
Status
Terminated
Date Initiated
11/14/2022
Location
Alpharetta, GA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
574 cartons

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.

Product Description

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

Distribution Pattern

Nationwide in the USA.

Other Recalls by Acella Pharmaceuticals, LLC

View all recalls by Acella Pharmaceuticals, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.