IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
Generic: IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
Aurobindo Pharma LimitedManufacturer
RESPIRATORY (INHALATION)Route
ALBUTEROL SULFATEActive Substance
2020-07-09Original Approval
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE is FDA application ANDA206532, sponsored by LUOXIN AUROVITAS. 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 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
266 reports
2
DRUG INEFFECTIVE
170 reports
3
PNEUMONIA
112 reports
4
FATIGUE
108 reports
5
COUGH
105 reports
6
NAUSEA
89 reports
7
HEADACHE
85 reports
8
DEATH
79 reports
9
DIZZINESS
74 reports
10
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
69 reports