Warren, N.J.-based Cipla USA, a subsidiary of India-based pharmaceutical company Cipla, recalled six batches of albuterol sulfate inhalation aerosol solutions after one complaint of the product leaking.
The drug is used in nebulizers to treat bronchospasm and other respiratory issues. It could be life-threatening if the device malfunctions and the medication leaks, the FDA said in a June 7 statement.
The recall of six batches of the 90 microgram solutions is "out of an abundance of precaution," the FDA said. No adverse events have been reported.
Albuterol inhalation solutions have been in constrained supply since March 2022, according to the American Society of Health-System Pharmacists. After an Illinois drugmaker closed in late February, the shortage worsened, with prolonged release dates and fewer available products. As of June 16, 11 solutions are on back order and four are not, according to the ASHP.
Drugmakers said they could not predict a resupply date.