Mylan Pharmaceuticals issued a nationwide voluntary recall of one lot of alprazolam — the generic equivalent for anti-anxiety drug Xanax — tablets due to the potential presence of a foreign substance, the company announced.
The recall is being carried out due to the potential presence of an unspecified "foreign substance," Mylan said in its announcement.
The recall affects a single batch of 0.5 mg alprazolam tablets, packaged in bottles of 500, that was distributed in the United States between July 2019 and August 2019. The lot number for the affected products is 8082708.
The company said that while the "clinical impact" of the foreign substance, if present, is expected to be rare, "the remote risk of infection to a patient cannot be ruled out."
As of Tuesday, Mylan had received no reports of adverse events.
Consumers affected by the recall should contact Stericycle at 888-843-0255 for a documentation packet to return the product, Mylan said. Retailers and wholesalers who think they may have been affected can find more information here.
Any questions regarding this voluntary recall can be directed to Mylan Customer Relations at 800-796-9526 Monday through Friday between 8 a.m. ET and 5 p.m. ET, or at firstname.lastname@example.org.
The FDA says that customers should contact their physician or healthcare provider if they have experienced any problems or adverse effects that may be related to using this drug product.
According to the company, Alprazolam tablets "are indicated for the management of anxiety disorder, the short-term relief of symptoms of anxiety, and the treatment of panic disorder, with or without agoraphobia."