Unique Pharmaceutical Laboratories voluntarily recalls four lots of cetirizine hydrochloride tablets

Unique Pharmaceutical Laboratories voluntarily recalls four lots of cetirizine hydrochloride tablets after identifying potential cross-contamination with ranitidine, a generic of Zantac. The company, a division of J. B. Chemicals & Pharmaceuticals Ltd., is recalling Cetirizine Hydrochloride Tablets USP 5 mg, the generic version of Zyrtec, for distribution to the consumer level. The firm said the risk is aimed at consumers with hypersensitivity to ranitidine ingredients, for whom ingestion of contaminated tablets could have a reasonable probability of serious adverse events, including life-threatening anaphylaxis and other severe hypersensitivity reactions. As of the recall notice, Unique reported it has not received any adverse-event reports. The recalled medication is packaged in 100-tablet HDPE bottles under NDC 16571-401-10. The affected lots—GY825029, GY825030, GY825031, and GY825032—were distributed nationwide with an expiration date of October 2028. Rising Pharma Holdings Inc. in East Brunswick, New Jersey, handled distribution, and Unique notified Rising to arrange returns. Consumers with questions can reach Rising by phone or email, and adverse reactions can be reported to the FDA MedWatch program.