IPRATROPIUM BROMIDE
Generic: IPRATROPIUM BROMIDE
Hikma Pharmaceuticals USA Inc.Manufacturer
NASALRoute
IPRATROPIUM BROMIDEActive Substance
2003-11-05Original Approval
IPRATROPIUM BROMIDE is FDA application ANDA076598, sponsored by HIKMA. 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 II2022-04-13
Ipratropium Bromide Inhalation Solution, 0.02%, 0.5 mg/2.5 mL, packaged in 25-count box (25 x 2.5 mL sterile unit-dose vcGMP deviations: Temperature abuse
Class II2024-03-26
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in t
Class II2015-08-21
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling proce
Class II2022-01-26
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage condi
Class III2022-04-13
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL vial, packaged in a) 30-count (NDC 0487-cGMP deviations: Temperature abuse
Top Reported Reactions
1
DYSPNOEA
1,945 reports
2
PNEUMONIA
1,072 reports
3
DRUG INEFFECTIVE
1,035 reports
4
COUGH
947 reports
5
FATIGUE
900 reports
6
NAUSEA
849 reports
7
OFF LABEL USE
776 reports
8
HEADACHE
716 reports
9
DIARRHOEA
700 reports
10
ASTHMA
655 reports