Mylan Pharmaceuticals initiated a nationwide voluntary recall of one lot of Alprazolam -- the prescription anti-anxiety drug sold under the name brand Xanax -- due to the potential presence of a foreign substance.
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"Clinical impact from the foreign material, if present, is expected to be rare, but the remote risk of infection to a patient cannot be ruled out," according to the Food and Drug Administration notice.
The recall is for Alprazolam Tablets, USP C-IV 0.5 mg, packaged in 500-count bottles that were distributed in July and August 2019.
The drug's lot No. is 8082708 and has a September 2020 expiration date.
The medicine is used for the management of anxiety disorder, the short-term relief of symptoms of anxiety, and the treatment of panic disorder, with or without agoraphobia.
Mylan notified its distributors and customers of the voluntary recall and is arranging for return of all recalled products, according to the recall notice.
To date, no one has reported having adverse events related to this batch.
Consumers are urged to contact Mylan Customer Relations at 800.796.9526 Monday through Friday from 8 a.m. – 5 p.m. Eastern Time or email firstname.lastname@example.org with any questions or concerns as well as their physician or healthcare provider.