NAPROXEN SODIUM
Generic: NAPROXEN SODIUM
TARGET CorporationManufacturer
ORALRoute
NAPROXEN SODIUMActive Substance
2018-03-15Original Approval
NAPROXEN SODIUM is FDA application ANDA208363, sponsored by PURACAP PHARM LLC. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class II2025-03-13
Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, PithCGMP Deviations
Class II2012-07-06
NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-BaLabeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-co
Class II2023-11-07
Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, GLabeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Class II2021-08-27
Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road MonroCGMP Deviations
Class II2021-08-27
Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc.,CGMP Deviations
Top Reported Reactions
1
DRUG INEFFECTIVE
2,946 reports
2
FATIGUE
2,691 reports
3
OFF LABEL USE
2,571 reports
4
PAIN
2,551 reports
5
RASH
2,333 reports
6
ARTHRALGIA
2,265 reports
7
DIARRHOEA
2,264 reports
8
VOMITING
2,207 reports
9
CONDITION AGGRAVATED
2,154 reports
10
JOINT SWELLING
2,134 reports