Allergy medication recall: Cetirizine tablets pulled over contamination risk

Allergy medication recall: Cetirizine tablets pulled over contamination risk centers on a U.S. FDA-described voluntary action by Unique Pharmaceutical Laboratories. The company, a division of J.B. Chemicals & Pharmaceuticals Ltd., recalled four lots of Cetirizine Hydrochloride Tablets USP 5 mg after determining the allergy medicine may be cross-contaminated with ranitidine. According to the FDA, the nationwide recall affects 100-count HDPE bottles distributed by Rising Pharma Holdings Inc. The issue was identified when a pharmacy technician noticed unusual tablets during dispensing, leading to a product complaint describing tablets with red dots and discoloration. Unique said consumers hypersensitive to ranitidine ingredients could face serious allergic reactions, including anaphylaxis, low blood pressure, breathing difficulty, trouble swallowing, swelling of the face and throat, widespread itching, hives, and loss of consciousness, and characterized these as life-threatening. Unique reported it has not received reports of adverse events. The recalled product is NDC 16571-401-10, in bottles labeled with lot numbers GY825029, GY825030, GY825031, and GY825032, all expiring October 2028. Rising has notified distributors and customers and is arranging returns, while the FDA said the recall is conducted with its knowledge.