Acella Pharmaceuticals, LLC: NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- 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 / hazard
- Chemical contamination; presence of lead and lithium above specification
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide
- Recall initiated
- 2026-04-20
- Code info
- Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
- Product quantity
- 6,336 bottles
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Alpharetta
- State
- GA
- Country
- United States
- Event id
- 98781
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