Indecopi Issues Alert Over US Recall of Cetirizine Tablets Due to Ranitidine Contamination

International drug regulators and consumer protection agencies have issued an urgent alert regarding an overseas medication recall involving cetirizine tablets potentially contaminated with ranitidina. According to the Instituto Nacional de Defensa de la Competencia y de la Protección de la Propiedad Intelectual (Indecopi), the warning stems from an international alert distributed by Peru’s Dirección General de Medicamentos, Insumos y Drogas (Digemid) following a recall initiated by the United States Food and Drug Administration (FDA).

FDA Recall Details and Affected Product Batches

The safety action impacts specific batches of “Cetirizine Hydrochloride Tablets USP 5 mg” packaged in bottles of 100 tablets. According to official regulatory documentation, the affected lots are GY825029, GY825030, GY825031, and GY825032. Unique Pharmaceutical Laboratories in India manufactured the medication, while Rising Pharma Holdings distributed the product in the United States. The impacted units carry expiration dates extending through October 2028.

Risk of Cross-Contamination With Ranitidine

Regulatory authorities traced the recall to potential cross-contamination with ranitidine during the manufacturing process. Health agencies warn that this unintended presence of ranitidine poses specific health risks, notably triggering hypersensitivity reactions in individuals allergic to the substance.

Consumer Guidance and Reporting Channels

While Indecopi continues investigating whether the affected batches entered the Peruvian commercial market through standard distribution channels, officials urge consumers to check any supplies obtained abroad or via online purchases. Citizens who identify the specified lots are advised to refrain from consuming them immediately. Digemid established reporting mechanisms for affected products, and international supplier inquiries can be directed to Rising Pharma Holdings via email at pv@risingpharma.com and qa@risingpharma.com. Additional details regarding the safety notice are accessible through Digemid’s official international alert portal, while domestic safety tracking is maintained through Indecopi’s consumer alert system.