Pharmaceutical firm Cipla Ltd on Friday said it is voluntarily recalling six batches of Albuterol Sulfate inhalation aerosol in the US market due to container defect.
The company's wholly-owned subsidiary, Cipla USA Inc, is voluntarily recalling the six batches of Albuterol Sulfate inhalation Aerosol 90 mcg, manufactured in November 2021, to the consumer level, Cipla Ltd said in a regulatory filing.
"The company is initiating a recall in the US due to a market complaint for one single inhaler (batch number - IB20056), where leakage was observed through the inhaler valve," it said.
Out of an abundance of precaution, Cipla further said the specified six batches manufactured using the same lot of valves are being recalled.
On the probable associated risk, the company said, "There is a reasonable probability that failure to deliver the recommended dose to treat the respiratory symptoms of an acute asthma exacerbations such as wheezing coughing, shortness of breath and bronchospasms, due to device defect, may be life-threatening." However, there were no adverse events reported for Albuterol Sulfate Inhalation Aerosol 90 mcg related to this recall, it added.
The product is used for the treatment and prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise induced bronchospasm.
It is packaged in 17ml plain aluminium aerosol canister integrated with a dose counter coupled with plastic actuator and dust cap, each pack claims 200 metered inhalations and associated codes NDC-69097-142-60, the filing said.
AdvertisementThese six batches were distributed nationwide to wholesalers and retailers.
"Cipla is notifying its distributors and customers by letter and is arranging for return and replacement of all recalled products. Consumers/distributors/retailers that have product from these six batches which are being recalled should stop using/return to place of purchase/discard," the company said.
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