Class II Recall

Acella Pharmaceuticals, LLC

Product
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16
Reason
Chemical contamination; presence of lead and lithium above specification
Classification
Class II
Status
Ongoing
Lot
Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.