Drug 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
D-0523-2026
Product summary
- Event
- Event 98781
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6,336 bottles
- Official record key
drug-enforcement:D-0523-2026
Official wording
Reason: Chemical contamination; presence of lead and lithium above specification
Code information: Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Chemical contamination