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
Chemical contamination; presence of lead and lithium above specification
Quick Facts at a Glance
- Recall Date
- April 20, 2026
- Hazard Level
- HIGH
- Brands
- NAPROXEN, Acella Pharmaceuticals, LLC
- Geographic Scope
- 1 states
Hazard Information
Chemical contamination; presence of lead and lithium above specification
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Acella Pharmaceuticals, LLC or your healthcare provider for guidance. Notification method: Letter
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Full 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. Generic: NAPROXEN; Brand: NAPROXEN. Reason: Chemical contamination; presence of lead and lithium above specification. Classification: Class II. Quantity: 6,336 bottles. Distribution: Nationwide
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