Viatris and Teva Pharmaceutical Industries recently launched separate recalls in the U.S. related to dissolution problems for a common anxiety medication and concerns around an unapproved raw material in a high blood pressure patch, respectively.
Both recalls were graded Class II, suggesting that use of the suspect meds could lead to temporary or reversible negative health effects. In both instances, the FDA determined that the probability of serious health risks to patients was remote.
In the case of Viatris, the drugmaker is pulling (PDF) one lot of extended release Xanax tablets, citing failed dissolution specifications, which concerns (PDF) how drugs are broken down to release their active ingredients in the body.
The recall pertains to 3-mg tablets in 60-count bottles that were produced in Ireland and distributed across the U.S. via Viatris Specialty in Morgantown, West Virginia, according to the FDA report.
Viatris initiated the recall on March 17. The action concerns a batch that was slated to expire at the end of next February. Viatris did not specify how many bottles were impacted.
As for Teva, the branded and generic drugs hybrid is yanking multiple lots of its clonidine transdermal system across 0.1-, 0.2- and 0.3-mg/day dosage forms, separate entries on this week’s FDA enforcement report note.
Teva’s medication-delivering patch is cleared for treatment of high blood pressure, and it is also used off label for other conditions like ADHD and anxiety, Quartz reports.
The clonidine patch batches were produced by Actavis Laboratories UT in Salt Lake City, with the pull coming down to good manufacturing practices deviations tied to the use of an “unapproved raw material,” the FDA’s report reads.
Last Month, the California State Board of Pharmacy released a dispatch (PDF) noting that the concerns around the raw material were linked to a “lack of extractable and leachable data for the unapproved raw material to establish safety of the drug product.”
The alert acknowledged that Teva’s own toxicological evaluation and health hazard assessment found that the product was unlikely to cause serious health issues and that the overall risk of harm to patients was “considered not applicable.”
Teva launched its ongoing recall on March 19, moving to pull seven total batches slated to expire as soon as this month and as late as next May.
Teva’s action follows an unrelated blood pressure med recall late last year.
In November, the company withdrew more than 500,000 bottles of the widely-used drug prazosin hydrochloride, citing higher-than-acceptable levels the cancer-linked impurity N-nitroso prazosin during deviation testing.
Nitrosamines, many of which are carcinogenic, are a group of compounds that can form under a variety of conditions, including during the storing or manufacturing of drugs.
