Teva issues another recall of antibiotics--this time from a Canadian plant

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.

Webinar

Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. This on-demand webinar discusses the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

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

Related Articles:
Teva recalls seizure drug 
Teva expects Allergan deal close any day, it says while lifting guidance
Allergan’s Actavis recalls nearly 600,000 bottles of ADHD drug
Teva retrieves amphetamines over impurity concerns

Suggested Articles

Teva will produce its new migraine drug at a plant in Israel and more news of note.

The shortage of childhood cancer drug vincristine was front and center during the Senate hearing for Stephen Hahn, nominee for FDA commissioner.

The FDA has lambasted the Torrent Pharmaceuticals in a warning letter for making OTC meds using water tainted with bacteria.