Product: Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-188-01.
Reason for recall: Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Recall initiated: 20231107
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated