TOPIC: Six Batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) by Cipla: Recall - Due to Container Defect
AUDIENCE: Patient, Health Professional, Pulmonology
ISSUE: Cipla Limited's wholly-owned subsidiary Cipla US is recalling six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) manufactured in November 2021 due to a market complaint for one single inhaler (Batch Number - IB20056), where leakage was observed through the inhaler valve. Out of an abundance of precaution, 6 batches manufactured using the same lot of valves are being recalled. The 6 batches were distributed Nationwide to wholesalers and retailers.
 Risk Statement: 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.
There were no adverse events reported for Albuterol Sulfate Inhalation Aerosol 90 mcg related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The product is used for the treatment and prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise induced bronchospasm.
RECOMMENDATIONS:
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Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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Patients/distributors/retailers that have product from these 6 batches which are being recalled should stop using/return to place of purchase/discard.
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Patients with questions, adverse reactions or quality problems regarding these 6 batches can contact the company.
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