Viatris and Teva Pharmaceutical Industries recently initiated separate recalls in the United States related to dissolution issues in a common anti-anxiety drug and concerns about unapproved ingredients in a high blood pressure patch, respectively.
Both recalls were graded Class II, suggesting that use of the suspected drugs could cause temporary or reversible adverse health effects. In both cases, the FDA determined that the potential for serious health risks to patients was low.
In the case of Viatris, the pharmaceutical company pulled one lot of extended-release Xanax tablets (PDF) due to failures in dissolution specifications for how the drug breaks down to release its active ingredient in the body.
According to the FDA report, the recall concerns 3mg tablets in 60-count bottles manufactured in Ireland and distributed throughout the United States through Viatris Specialty in Morgantown, West Virginia.
Viatris began the recall on March 17th. The measure concerns a batch that was due to expire at the end of February next year. Viatrice did not say how many bottles were affected.
As for Teva, the brand-generic drug hybrid company is pulling multiple lots of clonidine transdermal systems across dosage forms of 0.1, 0.2 and 0.3 mg/day, according to another entry in this week’s FDA enforcement report.
Teva’s drug delivery patch is approved to treat high blood pressure and is also used off-label for other conditions such as ADHD and anxiety, Quartz reports.
The batch of clonidine patches are manufactured by Actavis Laboratories UT in Salt Lake City and are due to violations of good manufacturing practices related to the use of “unapproved ingredients,” the FDA report said.
Last month, the California State Board of Pharmacy issued a notice (PDF) noting that concerns about ingredients were related to “the lack of extractable and leachable data for unapproved ingredients to establish drug safety.”
The warning acknowledges that Teva’s own toxicological and health hazard assessments have determined that the product is unlikely to pose a serious health problem and that the overall risk of harm to patients is “not considered to be applicable.”
Teva began the ongoing recall on March 19 and is moving to recall a total of seven batches that are set to expire as early as this month or as late as May next year.
Teva’s action follows a recall of an unrelated blood pressure drug late last year.
In November, the company recalled more than 500,000 bottles of the widely used drug prazosin hydrochloride after a deviation test found that the concentration of the cancer-related impurity N-nitrosoprazosin exceeded acceptable limits.
Nitrosamines are a group of compounds that are often carcinogenic and can form under a variety of conditions, including during storage and manufacturing of pharmaceutical products.
