The Food and Drug Administration (FDA) this week upgraded a recall of a type of antihistamine to its most severe level due to cross-contamination.
JB Chemicals and Pharmaceuticals Ltd. of India is recalling several lots of cetirizine hydrochloride tablets in 5-milligram doses, according to a notice published by the FDA, updated Aug. 3. The action impacts 34,020 100-count bottles nationwide, it said.
There were “customer complaints for appearance of discolored tablets and red dots observed on” the cetirizine tablets. It was determined to be ranitidine, a medication that is primarily used to treat heartburn, ulcers, and acid reflux disease.
Consumers who have a heightened sensitivity to ranitidine, JB Chemicals said, may see a “reasonable probability that ingestion of cetirizine tablets contaminated with ranitidine could result in serious adverse events including severe hypersensitivity reactions and anaphylaxis.” …