BENGALURU (Reuters) -Indian drugmaker Cipla said on Friday its U.S. unit was recalling six batches of albuterol sulfate inhalation aerosol due to a “container defect”.
“The company is initiating a recall in the U.S. due to a market complaint for one single inhaler, where leakage was observed through the inhaler valve,” the pharmaceutical company said in a statement.
The six batches, manufactured in November 2021 using the same lot of valves, are being recalled, the company added.
The company’s “Albuterol Sulfate HFA Inhalation Aerosol” is a generic therapeutic equivalent version of an inhaler from Merck & Co, according to Cipla’s website.
Cipla said there were no adverse events reported for the inhaler related to the recall.
But a failure to deliver the recommended dose to treat the respiratory symptoms of acute asthma exacerbations, including wheezing and bronchospasms, due to a device defect, could be “life-threatening”, Cipla added.
Albuterol sulfate inhalation aerosol is used for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
Cipla also said consumers should stop using, return to place of purchase or discard the inhalers. It also added that adverse reactions with the use of the product could be reported to the U.S. health agency.
Shares of Cipla were trading 0.7% lower as of 9:45 a.m. IST.
(Reporting by Nishit Navin in Bengaluru; Editing by Krishna Chandra Eluri)
