FDA-Drug2023-12-06Class II

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.

Glenmark Pharmaceuticals Inc., USA
Hazard

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Sold states
Nationwide
Manufactured in
750 Corporate Dr, Mahwah, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0124-2024

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