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Mylan Pharmaceuticals is voluntarily recalling one lot of the anti-anxiety prescription drug Alprazolam nationwide because of “the potential presence of a foreign substance,” according to a recall notice posted on the Food and Drug Administration website.
Alprazolam is a generic form of Xanax.
“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,” the notice states. “To date, Mylan has not received any adverse events related to this batch.”
The recall is for Alprazolam 0.5 mg tablets that were distributed in July and August 2019 in 500-count bottles. The affected drug’s lot No. is 8082708 and it has a September 2020 expiration date.
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According to the recall notice, Mylan has notified its distributors and customers about the recall by letter and is arranging for return of all recalled products. Retailers are being asked to contact consumers to explain the return process.
To return the Alprazolam, consumers should call Stericycle at 888-843-0255. Consumers with questions should call Mylan at 800-796-9526, Monday through Friday, 8 a.m. to 5 p.m. Eastern time, or email at email@example.com.
The medicine is for the management of anxiety disorder, the short-term relief of symptoms of anxiety, and the treatment of panic disorder, with or without agoraphobia, according to Mylan.
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