ACETYLCYSTEINE
Generic: ACETYLCYSTEINE
Hikma Pharmaceuticals USA Inc.Manufacturer
INTRAVENOUSRoute
ACETYLCYSTEINEActive Substance
2023-04-19Original Approval
ACETYLCYSTEINE is FDA application ANDA217182, sponsored by ONESOURCE SPECIALTY. 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 II2026-07-24
ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25xPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, gla
Class II2026-07-24
ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25xPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, gla
Top Reported Reactions
1
DYSPNOEA
771 reports
2
OFF LABEL USE
668 reports
3
DRUG INEFFECTIVE
658 reports
4
PNEUMONIA
634 reports
5
PYREXIA
508 reports
6
FATIGUE
455 reports
7
NAUSEA
434 reports
8
DIARRHOEA
349 reports
9
VOMITING
333 reports
10
DEATH
315 reports