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| The United States: Cipla Issues Voluntary Nationwide Recall of Six Batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) Due to Container Defect (English only) |
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The US Food and Drug Administration (FDA) announces that Cipla Limited’s wholly-owned subsidiary Cipla US is voluntarily recalling six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) manufactured in November 2021 to the consumer level.
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.
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. Out of an abundance of precaution, the following mentioned 6 batches manufactured using the same lot of valves are being recalled.
The affected products are:
- Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) (Batch Number: IB20045, IB20055, IB20056, IB20057, IB20059, IB20072)
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cipla-issues-voluntary-nationwide-recall-six-batches-albuterol-sulfate-inhalation-aerosol-90-mcg-200
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Saturday, Jul 8, 2023
Issued at HKT 12:00
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