US unit of India's Cipla recalls six batches of bronchospasm inhaler
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[July 07, 2023]
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.
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Employees and security staff work at the
reception area of Cipla at its headquarters in Mumbai, India June
17, 2015. REUTERS/Danish Siddiqui/File Photo
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)
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