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Recall of Generic Version of Xanax Is Announced by F.D.A.


The Food and Drug Administration has announced a nationwide recall of a batch of alprazolam, a generic version of Xanax, because of potential contamination.

The manufacturer, Mylan Pharmaceuticals, said Friday that the voluntary recall was because of the possible presence of a foreign substance. The company had not received reports of problems related to the tablets, but “the remote risk of infection to a patient cannot be ruled out,” it said. A Mylan spokeswoman did not immediately respond to questions about what the contaminant was.

Alprazolam is prescribed to manage anxiety and panic disorders. The affected batch of .5-milligram doses was distributed in the United States in 500-tablet bottles in July and August, with an expiration date of September 2020, the company said.

Credit...U.S. Food and Drug Administration

Jeremy Kahn, a spokesman for the F.D.A., said that patients who filled prescriptions for the drug during those months should consult their pharmacist.

Mylan said that it had sent letters to distributors, and called for wholesalers and retailers to examine their inventory, stop distributing the affected batch and notify customers.

The company, which is based in Canonsburg, Pa., mainly produces generic drugs, and is best known for its EpiPen emergency allergy treatment.


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