FDA-Drug2021-09-29Class II

Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Glenmark Pharmaceuticals Inc., USA
Hazard

CGMP Deviations

Sold states
Nationwide.
Affected count
9552 bottles
Manufactured in
750 Corporate Dr, Mahwah, NJ, United States
Products
Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0821-2021

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