PYRIDOSTIGMINE BROMIDE

Generic: PYRIDOSTIGMINE BROMIDE

Novadoz Pharmaceuticals LLCManufacturer
ORALRoute
PYRIDOSTIGMINE BROMIDEActive Substance
2023-09-21Original Approval

PYRIDOSTIGMINE BROMIDE is FDA application ANDA216512, sponsored by MSN. 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 II2022-09-30
Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: Vi

cGMP Deviations: Out of specification for assay of one of the preservative ingredients.

Top Reported Reactions

1
MYASTHENIA GRAVIS
186 reports
2
FATIGUE
158 reports
3
DRUG INEFFECTIVE
141 reports
4
DYSPNOEA
140 reports
5
OFF LABEL USE
122 reports
6
ASTHENIA
117 reports
7
HEADACHE
108 reports
8
DIARRHOEA
105 reports
9
MALAISE
89 reports
10
NAUSEA
88 reports