Recalled: Viatris Xanax Lot, Teva's 7 Clonidine Batches
FDA graded two separate recalls Class II this week: Viatris pulling extended-release Xanax over failed dissolution specs, Teva yanking clonidine patches over an unapproved raw material.
Viatris initiated its pull on March 17, targeting one lot of 3-mg Xanax in 60-count bottles, manufactured in Ireland and distributed across the U.S. via Viatris Specialty in Morgantown, West Virginia. Dissolution failure means the tablets aren’t breaking down properly to release their active ingredient. The batch was set to expire at the end of February.
No bottle count was disclosed.
Teva’s March 19 recall covers seven lots of its clonidine transdermal system across 0.1-, 0.2-, and 0.3-mg/day strengths, manufactured by Actavis Laboratories UT in Salt Lake City. The patch is cleared for high blood pressure, though it’s also used off label for ADHD and anxiety.
FDA’s enforcement report tied the recall to good manufacturing practices deviations involving an “unapproved raw material.” California’s State Board of Pharmacy cited the specific concern as a lack of extractable and leachable data to establish the product’s safety. Teva’s own toxicological review found overall patient risk “considered not applicable,” but the recall is ongoing.
For Teva, it’s the second recall in under six months. In November, the company pulled more than 500,000 bottles of prazosin hydrochloride over elevated levels of N-nitroso prazosin, a cancer-linked impurity.
Teva’s clonidine batches expire as soon as this month, others as late as next May.
— Sarah Chen
