Cipla Albuterol Sulfate Inhalation Aerosol Voluntarily Recalled

On July 6, 2023, Cipla US recalled six batches of its albuterol sulfate inhalation aerosol, 90 mcg (200 MI). According to the release published by the FDA on July 7, 2023, the company cited a container defect that delivered an improper dose as the reason for the recall.

The following batches, scheduled to expire in November 2023, have been recalled: IB20045, IB20055, IB20056, IB20057, IB20059, and IB20072. The medications were manufactured in November 2021 and were distributed to consumers then.

The company was notified of this issue when a market complaint for a single defective inhaler from batch IB20056 was submitted. Upon deeper analysis, Cipla noted that the inhaler valve had some leakage. Based on that analysis, the company recalled all inhalers manufactured using the same batch of valves.

These inhalers are prescribed to prevent and treat bronchospasms with reversible obstructive airway disease, including asthma, chronic bronchitis, and emphysema. The medication is also routinely prescribed for patients with exercise-induced bronchospasms.

With leaks in the valves, the inhalers may be delivering an inadequate amount of medication to patients. According to the Cleveland Clinic, bronchospasms are a tightening of the muscles in the bronchi, usually resulting in wheezing, coughing, chest tightness, shortness of breath, fatigue, and dizziness.

Although albuterol and other bronchodilators can be used to manage bronchospasms, a reduced dosage can result in exacerbated, life-threatening symptoms.

Cipla’s press release urges that all consumers, distributors, and retailers that have products from each of these batches should stop using, return, or discard them. The company arranges returns and replacements, notifying consumers via public messaging and letters.

Adverse reactions from patients using these products should be reported to the FDA’s MedWatch Adverse Event Reporting program.

The recall occurred during ongoing shortages of albuterol sulfate, which began in February 2023 after Akorn Pharmaceuticals, a major domestic manufacturer, filed for bankruptcy. As of June 16, 2023, the American Society of Health Systems Pharmacists lists multiple albuterol sulfate inhalation solutions that are in short supply.

Providers should consider prescribing alternative bronchodilators, such as levalbuterol hydrochloride inhalation solution when possible.