For the second time this year, Teva ($TEVA) has issued a recall of antibiotics produced at one of its facilities. This time it’s a plant in Canada.
In the most recent action, the company said it is recalling more than 53,000 bottles of amoxicillin manufactured by Teva Canada Limited in Toronto.
According to an FDA enforcement report, the nationwide voluntary recall of the antibiotic was initiated because it is considered a “superpotent drug” on the basis of an out of specification test result for assay during stability testing. The regulatory agency has classified the recall as a Class II event, which means there isn’t an immediate threat of death or danger from the product.
Earlier this year, the drugmaker began recalling amikacin sulfate from its facility in Hungary due to the potential for the presence of glass particulate, which the company said could cause reactions from swelling to blood clots. Teva recently expanded that recall to 7 additional lots made at the plant in Gödöllő, Hungary, which the FDA put on its import alert this year.
In May, the Israel-based drugmaker recalled 14,370 units of divalproex sodium delayed-release tablets, which are used to treat certain types of epileptic seizures, as well as for bipolar disorder and migraines, after they failed unspecified specifications.
– check out the FDA enforcement report
thanks to: FiercePharma