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

Recall Number: D-0523-2026

Firm: Acella Pharmaceuticals, LLC

Classification: Class II

Status: Ongoing

Report Date: 20260513

Initiation Date: 20260420

Termination Date:

Reason for Recall

Chemical contamination; presence of lead and lithium above specification

Product Description

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

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