Anti-anxiety med recalled due to ‘foreign substance’ and infection risk

Mylan Pharmaceuticals Inc. is recalling one lot of the anti-anxiety medication alprazolam — commonly sold under the brand name Xanax — “due to the potential presence of foreign substance,” the company said last week.

The company said the likelihood that someone would fall ill “is expected to be rare, but the remote risk of infection to a patient cannot be ruled out.” Mylan added that, as of the announcement on Friday, it had not gotten any reports of adverse events linked to that particular lot.

Mylan declined to provide additional information about the product or foreign substance.

The voluntary recall includes a single lot of bottles, each containing 500 0.5-milligram tablets, that were distributed in the United States between July and August. The lot number affected was 8082708, and the expiration date is listed as September 2020.

Instructions for wholesalers, retailers and consumers to return recalled bottles can be found in the company’s announcement, which was also posted to the US Food and Drug Administration’s website. Adverse events can be reported to the agency’s MedWatch Adverse Event Reporting program.