Sun Pharmaceutical, which has been dealing with FDA concerns over plants in India, is now recalling more than 12,000 bottles of a beta blocker made at a plant in Hungary.
According to the most recent FDA Enforcement Report, Sun is recalling 12,109 bottles of Carvedilol tablets manufactured at its Alkaloida Chemical site in Tiszavasvari, Hungary.
The voluntary recall, which has just been classified by the FDA, began in June. The four recalls were initiated after the products failed impurities and degradation testing, the report says.
In June, Sun also began a recall of 16,085 bottles of the antidepressant bupropion hydrochloride extended-release tablets manufactured at its Halol, India, plant because they failed specifications for dissolution.
The plant is one of Sun’s primary facilities for providing products to the U.S., so Sun saw sales slip after the FDA cited its Halol plant with a Form 483 in 2014. The agency issued a warning letter to the plant last December for a host of quality and data integrity issues, and the drugmaker recalled a number of products as a result.