Nationwide recall of Xanax issued due to potential of foreign substance

Nationwide recall of Xanax issued due to potential of foreign substance (Cropped Photo: Steve Snodgrass / Flickr / CC BY 2.0 via MGN Online)

Nationwide recall of Xanax issued due to potential of foreign substance (Cropped Photo: Steve Snodgrass / Flickr / CC BY 2.0 via MGN Online)

WASHINGTON (WJLA) — A voluntary nationwide recall of the drug Xanax (generic name alprazolam) is being conducted by its manufacturer, Mylan Pharmaceuticals Inc., the FDA announced Saturday.

The tablets potentially have a “foreign substance” present in them.

“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. To date, Mylan has not received any adverse events related to this batch,” the FDA’s statement said.

The recalled tablets are from one lot of Alprazolam Tablets, USP C-IV 0.5 mg, that were packaged in bottles of 500. This batch was distributed in the U.S. between July 2019 and August 2019.

The lot number is 8082708 and the national drug code is 0378-4003-05.

Mylan has notified its distributors and customers by letter and is arranging for return of all recalled products, says the FDA, which recommends the following actions for wholesalers, retailers and consumers:

Wholesaler: Immediately examine your inventory, quarantine and discontinue distribution of these lots. In addition, if you have further distributed the product, please identify your retail level customers and provide a list of customers via Microsoft excel file to mylan5924@stericycle.com within 10 business days. Stericycle will notify your retail level customers that received the affected batches.

Retailer: Immediately examine your inventory, quarantine and discontinue distribution of these lots. Additionally, if you have further distributed the product, please identify the consumer and notify them immediately of this product recall. The consumer should be instructed to contact Stericycle at 1-888-843-0255 for the documentation packet to return the product.

Consumer: Please contact Stericycle at 1-888-843-0255 for the documentation packet to return product to Stericycle.