The recall affects Albuterol Sulfate Inhalation Aerosol, 90mcg, specifically batches manufactured in November 2021.
Pharmaceutical company Cipla has initiated a recall of six specific batches of Albuterol Sulfate Inhalation Aerosol due to a defect in the container. This decision was reached after the discovery of a leakage through the inhaler valve in one of the batches. The aerosol is vital for the treatment of acute asthma exacerbations, and the defect could lead to life-threatening consequences, although no adverse events have been reported thus far.
- Six batches have been recalled, with batch numbers including IB20045, IB20055, IB20056, IB20057, IB20059, and IB20072, all expiring in November 2023.
- A leakage was observed in one inhaler in batch number IB20056, leading to the recall from an abundance of caution.
- The defect may prevent the recommended dose from being delivered, potentially resulting in serious consequences.
- Replacement inhalers should be obtained by consumers from the affected batches.
- Adverse events can be reported to the FDA’s MedWatch program.
- Further information is available through Cipla’s customer service via phone or email.
- This recall serves as a precautionary measure to prevent any potential harm that might arise from the container defect, and prompt action is required to ensure patient safety.
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According to the World Health Organization, asthma affects approximately 339 million people globally and causes around 417,000 deaths annually.