Cipla-led arm recalls six batches of Albuterol Sulfate Inhalation

7 Jul 2023 , 01:27 PM

Cipla Limited announced that Cipla USA Inc., its wholly-owned subsidiary, is recalling six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) voluntarily. These batches were manufactured in November 2021 to the consumer level.

The company stated in its risk statement that failure to deliver the recommended dose to treat the respiratory symptoms of an acute asthma exacerbation, such as wheezing, shortness of breath, coughing, and bronchospasms, due to device defect, has a reasonable chance of being fatal.

There were no reported adverse events for Albuterol Sulphate Inhalation Aerosol 90 mcg before this recall, said the company.

The Company is conducting a recall in the United States in response to a market complaint for a single inhaler (Batch Number – IB20056), where leakage was observed through the inhaler valve. As a precaution, the above-mentioned six batches manufactured with the same lot of valves are being recalled.

Cipla has informed its distributors and customers via letter, and arranged for the return and replacement of all recalled products. Consumers/distributors/retailers who have product from these six recalled batches should stop using it, return it to the place of purchase, or discard it, said the company.

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