Boehringer Ingelheim Initiates Recalls

Boehringer Ingelheim recalled 2.2 million Zantac tablets last month because the drug exceeded limits for S-oxide, an impurity.

DMS Pharmaceuticals manufactured the tablets, which were distributed nationwide, according to the FDA’s Enforcement Report. Zantac (ranitidine) is an OTC drug indicated for the relief of heartburn associated with acid indigestion. The recall is a Class III.

Separately, Boehringer Ingelheim subsidiary Ben Venue Laboratories recalled 153,270 vials of ventricular fibrillation medicine amiodarone HCl. The Class III recall was initiated because of the presence of particulate matter. Amiodarone vials contained crystallized active ingredient.