FDA-Drug2021-09-29Class II
Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05
Glenmark Pharmaceuticals Inc., USA
Hazard
CGMP Deviations
Sold states
Nationwide.
Affected count
a) 31248 bottles; b) 300 bottles
Manufactured in
750 Corporate Dr, Mahwah, NJ, United States
Products
Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0822-2021Don't want to check this manually?
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