ARFORMOTEROL TARTRATE

Generic: ARFORMOTEROL TARTRATE

Lifestar Pharma LLCManufacturer
RESPIRATORY (INHALATION)Route
ARFORMOTEROL TARTRATEActive Substance
2022-11-15Original Approval

ARFORMOTEROL TARTRATE is FDA application ANDA216128, sponsored by MANKIND PHARMA. 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 II2022-09-29
Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dos

Lack of Assurance of Sterility: environmental monitoring failure.

Top Reported Reactions

1
DYSPNOEA
52 reports
2
FATIGUE
28 reports
3
PNEUMONIA
24 reports
4
COUGH
20 reports
5
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
19 reports
6
DRUG INEFFECTIVE
19 reports
7
DIARRHOEA
16 reports
8
ASTHENIA
15 reports
9
OXYGEN SATURATION DECREASED
13 reports
10
PERIPHERAL SWELLING
13 reports