NITROGLYCERIN
Generic: NITROGLYCERIN
Advagen Pharma LtdManufacturer
SUBLINGUALRoute
NITROGLYCERINActive Substance
2021-05-03Original Approval
NITROGLYCERIN is FDA application ANDA209779, sponsored by RUBICON RESEARCH. 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 II2021-12-27
Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, YeruDefective Delivery System
Class II2025-03-13
Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, PiCGMP Deviations
Class I2013-11-18
50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPD
Class II2026-07-24
Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, gla
Class II2025-03-13
Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur,CGMP Deviations
Top Reported Reactions
1
DYSPNOEA
3,422 reports
2
PAIN
3,122 reports
3
FATIGUE
2,736 reports
4
MYOCARDIAL INFARCTION
2,696 reports
5
NAUSEA
2,629 reports
6
FALL
2,415 reports
7
CHEST PAIN
2,363 reports
8
DIZZINESS
2,338 reports
9
DRUG INEFFECTIVE
2,321 reports
10
HEADACHE
2,149 reports