Bella Pharmaceuticals recalls all lots of unexpired sterile drug products

Image: A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo

Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance, said the FDA. The recalled products were distributed to health care facilities in the USA.

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, Bella Pharmaceuticals has not received any reports of adverse events.

You can find more about the products listed here.

The FDA said that the affected products include all lots distributed April 17, 2017, to August 10, 2017, remaining within expiry, and they would be packaged in a syringe, vial or eye dropper.

“Bella Pharmaceuticals has a longstanding commitment to quality and safety.  We are voluntarily issuing a recall out of an abundance of caution after several issues were identified during a recent FDA inspection of our facility,” Michael Younan, Chairman and CEO of Bella Pharmaceuticals. “We regret any impact this recall has on our loyal customers and their patients.”