The adulterating substance, which was only identified as a ‘foreign substance’, led to a voluntary recall from the consumer level of one lot of alprazolam tablets 0.5mg.
The product is more commonly known by its branded name, Xanax, and is a treatment for anxiety and panic disorders.
Mylan noted in its release that any ‘clinical impact’ from the foreign material present is ‘expected to be a rare’, though it did indicate that there is a potential risk of infection that could not be ruled out.
The affected batch was distributed in the US between July and August 2019.
The company stated that it had notified distributors and customers of its decision to recall product.
Earlier this year, Mylan had also issued a recall of two lots of levoleucovorin injection, after stability testing revealed that copper salts were present in the sterile injectable.