FDA recalls cetirizine tablets over ranitidine contamination

A widely used over-the-counter allergy medication is being recalled nationwide after some tablets were found to be potentially contaminated with a completely different drug used for heartburn. Unique Pharmaceutical Laboratories voluntarily recalled four specific lots of its Cetirizine Hydrochloride Tablets USP 5 mg due to a risk of cross-contamination with ranitidine, according to the U.S. Food and Drug Administration. The recall was announced by the manufacturer on July 18, with the FDA publishing its official notice on July 20.

The issue was discovered when a pharmacy technician, while counting tablets, noticed a red dot on some pills and discoloration on others, prompting an investigation. The subsequent analysis identified possible contamination with ranitidine, a medication that reduces stomach acid. While both cetirizine, a common antihistamine for allergy relief, and ranitidine are antihistamines, they target different systems in the body. The FDA warned that for consumers with a hypersensitivity to ranitidine's ingredients, ingesting the contaminated allergy tablets could result in serious, potentially life-threatening adverse events.

These reactions include severe...