Generic Xanax Recall Issued Due To Foreign Substance That May Cause Infections

Mylan Pharmaceuticals recalled certain bottles of generic Xanax tablets last week, due to a risk that contaminants may place users of the anxiety drug at risk of developing an infection.

The FDA announced a alprazolam tablets recall on October 26, after routine testing by Mylan identified foreign material that may have entered the prescription medication during production. While no injuries or adverse health consequences have been reported to date, the recall notice indicates that the contaminants may pose a serious infection risk for patients.

Alprazolam is a prescription drug sold under the name brand Xanax, which is prescribed to manage anxiety disorders, provide short-term relief of symptoms of anxiety, and to treat panic disorder, with or without agoraphobia.

The generic Xantax recall includes one lot of Alprazolam tablets, USP C-IV 0.5 mg packaged in bottles of 500 and marked with NDC number 0378-4003-05 and Lot number 8082708. According to the recall notice, the recalled lot was marked with an expiration date of September 2020.

The recalled tablets were manufactured by Mylan Pharmaceuticals Inc. of Morgantown, West Virginia. They were distributed throughout the United States to retailers from July 2019 through August 2019.

Mylan is notifying its customers and distributors by letter and has arranged for a return of all products at the wholesale, retail and consumer level. The company is instructing retailers and wholesalers to immediately examine their inventory, and to quarantine and discontinue the distribution of the impacted lot. At the user level, customers are being asked to stop taking the medication immediately and to contact Stericycle at 1-888-843-0255 for return instructions.

The recall notice indicates the clinical impact from the foreign material, which is not identified in the notice, may be rare. However, Mylan warns the risk of infection to a patient could occur and pose a risk of serious adverse health consequences.

Customers are being asked to contact their physician or healthcare provider if they have experienced any problems that could be related to the medication. Those with questions or concerns regarding the recall are encouraged to contact Mylan Customer Relations at 800-796-9526 or email them at customer.service@mylan.com.