Safety Report: Cipla Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI)- recalled due to Failure to deliver the recommended dose, USA

United States

Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as "Cipla"), today announced that its 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 due to Failure to deliver the recommended dose. These 6 batches were distributed Nationwide to wholesalers and retailers. There were no adverse events reported related to this recall.

The affected products are:
Sr. No. Product Name Batch No. Expiry Date
1. Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) IB20045 Nov.2023
2. Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) IB20055 Nov.2023
3. Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) IB20056 Nov.2023
4. Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) IB20057 Nov.2023
5. Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) IB20059 Nov.2023
6. Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) IB20072 Nov.2023

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.

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.

The product is used for the treatment and prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise induced bronchospasm. The product is packaged in 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.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Cipla
Brand name: Cipla
Product recalled: Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation)
Reason of the recall: Failure to deliver the recommended dose
FDA Recall date: July 07, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cipla-issues-voluntary-nationwide-recall-six-batches-albuterol-sulfate-inhalation-aerosol-90-mcg-200