NAPROXEN SODIUM HEADACHE PAIN
Generic: NAPROXEN SODIUM
Aurohealth LLCManufacturer
ORALRoute
NAPROXEN SODIUMActive Substance
2016-03-18Original Approval
NAPROXEN SODIUM HEADACHE PAIN is FDA application ANDA205497, sponsored by AUROBINDO PHARMA LTD. 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 II2026-04-20
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLChemical contamination; presence of lead and lithium above specification
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
11,959 reports
2
PAIN
10,431 reports
3
FATIGUE
9,353 reports
4
ARTHRALGIA
8,829 reports
5
NAUSEA
8,562 reports
6
OFF LABEL USE
7,621 reports
7
HEADACHE
7,246 reports
8
DIARRHOEA
6,984 reports
9
VOMITING
6,350 reports
10
RASH
6,181 reports