Acella Pharmaceuticals, LLC — Class II: NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed
Acella Pharmaceuticals, LLC has initiated a Class II recall for Naproxen Oral Suspension, USP (125 mg/5mL) due to chemical contamination, specifically the presence of lead and lithium above specification.
This recall affects Acella Pharmaceuticals, LLC, retail pharmacies, and healthcare providers distributing this specific NDC (42192-619-16), as well as internal Quality and Compliance departments.
The presence of elemental impurities above specification suggests potential failures in the manufacturing process or raw material sourcing. For regulatory teams, this indicates a need to scrutinize the Canadian manufacturing facility's compliance with compendial standards and current Good Manufacturing Practices (cGMP) regarding impurity controls.
Quality and Regulatory teams should verify the purity of incoming raw materials or finished product batches from the cited manufacturing site. Review existing stability and screening protocols for heavy metal and elemental impurity testing to ensure alignment with USP specifications.
Class II. Reason: Chemical contamination; presence of lead and lithium above specification. 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. Firm: Acella Pharmaceuticals, LLC (Alpharetta GA United States). Status: Ongoing.
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