LEVALBUTEROL INHALATION SOLUTION
Generic: LEVALBUTEROL INHALATION SOLUTION
Sun Pharmaceutical IndustriesManufacturer
RESPIRATORY (INHALATION)Route
LEVALBUTEROL HYDROCHLORIDEActive Substance
2018-11-05Original Approval
LEVALBUTEROL INHALATION SOLUTION is FDA application ANDA207820, sponsored by SUN PHARM. 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 II2021-03-15
Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inhalations Net Contents: 15 g Rx Only NDC 059CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II2022-04-13
Levalbuterol Tartrate HFA Inhalation Aerosol, 45 mcg/actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, cGMP deviations: Temperature abuse
Top Reported Reactions
1
DYSPNOEA
637 reports
2
DEVICE DELIVERY SYSTEM ISSUE
532 reports
3
DRUG DOSE OMISSION BY DEVICE
464 reports
4
NO ADVERSE EVENT
434 reports
5
PNEUMONIA
378 reports
6
COUGH
329 reports
7
ASTHMA
312 reports
8
DRUG INEFFECTIVE
311 reports
9
FATIGUE
298 reports
10
OFF LABEL USE
298 reports