Glenmark Recalls Over 11,000 Ziac Bottles for Contamination

Glenmark Pharmaceuticals Inc. has recalled more than 11,000 bottles of its blood pressure medication Ziac nationwide after testing revealed trace contamination with a cholesterol-lowering drug, the U.S. Food and Drug Administration announced on December 1.

The recall affects 11,136 bottles of bisoprolol fumarate and hydrochlorothiazide tablets, a combination drug commonly prescribed to treat hypertension. Reserve samples tested at the manufacturer's facility showed the presence of ezetimibe, which Glenmark also produces. The company, based in Elmwood Park, New Jersey, initiated the action following routine quality checks that detected the cross-contamination, likely occurring during production. The FDA classified the recall as Class III, indicating that use of or exposure to the affected product is not likely to cause adverse health consequences. No adverse reactions have been reported to date.

The contaminated tablets are in 2.5 milligram bisoprolol fumarate and 6.25 milligram hydrochlorothiazide doses. They were distributed in 30-count bottles with National Drug Code 6846287830, 100-count bottles with NDC 6846287801, and 500-count bottles with NDC 6846287805. The impacted lots...