At least one lot of a popular anti-anxiety drug is facing a nationwide recall over concerns there is a “potential presence of [a] foreign substance,” in the product, the Food and Drug Administration (FDA) announced late last week.
Mylan Pharmaceuticals is voluntarily recalling one lot of its Alprazolam Tablets, a prescription drug typically sold under the name brand 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,” reads the recall notice posted to the FDA’s website on Friday. As of the same day, the federal agency had not received any reports of adverse events related to the recalled batch.
It’s unclear what the foreign material is.
The recall was prompted over concerns the products contains a “foreign substance.”
The recall affects Alprazolam Tablets, USP C-IV, 0.5 mg in 500-count bottles, lot No. 8082708. The bottles have a September 2020 expiration date and were distributed across the U.S. between July and August, officials said.
“Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product,” the notice adds.
Anyone with further questions about the recall can contact Mylan at 800-796-9526 or email@example.com.