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Drugmaker Cipla is voluntarily recalling six batches of Albuterol Sulfate Inhalation Aerosol, in the US.
The US recall follows 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, the above mentioned 6 batches manufactured using the same lot of valves, are being recalled,” Cipla added..
The batch was manufactured in November 2021 and the recall was through its wholly-owned subsidiary, Cipla USA Inc.“There were no adverse events reported for Albuterol Sulfate Inhalation Aerosol 90 mcg related to this recall,” it said.
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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 a 17ml plain aluminium aerosol canister integrated with dose counter, coupled with plastic actuator and dust cap, each pack claims 200 metered inhalations and associated codes NDC-69097-142-60, a company statement said.
On the risk involved, it said, “there was a reasonable probability that failure to deliver the recommended dose to treat the respiratory symptoms of acute asthma exacerbations such as wheezing coughing, shortness of breath and bronchospasms, due to device defect, may be life-threatening.”
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These 6 batches were distributed nationwide to wholesalers and retailers, Cipla said, and it was notifying its distributors and customers by letter and was arranging for the return and replacement of all recalled products. “Consumers/ distributors/ retailers that have products from these 6 batches which are being recalled, should stop using/ return to place of purchase/ discard,” it added. .
Source: Cipla
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