FDA Warns of Cetirizine Antihistamine Recall Due to Contamination

The U.S. Food and Drug Administration (FDA) issued a warning this week regarding a voluntary recall of certain lots of Cetirizine Hydrochloride Tablets USP, 5 mg. The recall was initiated by Unique Pharmaceutical Laboratories over the weekend due to potential cross-contamination with Ranitidine, a medication used to treat ulcers and stomach acid issues. This contamination poses a risk of "serious adverse events," including "life-threatening" reactions such as severe hypersensitivity, anaphylaxis, hypotension, dyspnea, difficulty swallowing, throat and facial edema, generalized pruritic, urticaria, and loss of consciousness, particularly in individuals hypersensitive to Ranitidine's ingredients.

The issue came to light when a pharmacy technician discovered a discrepancy while dispensing the tablets. Following this observation, Unique Pharmaceuticals investigated the report and subsequently notified its distributor, Rising Pharma Holdings, leading to the initiation of the voluntary recall. The affected products are specifically four lots of Cetirizine Hydrochloride Tablets USP, 5 mg, packaged in HDPE Bottle packs of 100 tablets. The National Drug Code (NDC) for these recalled products is 16571-401-10.

Cetirizine Hydrochloride Tablets are commonly used to alleviate allergy symptoms such as sneezing, runny nose, and itchy or watery eyes. The FDA's alert emphasizes the critical nature of the potential contamination, urging individuals to avoid the specified recalled lots. The agency's warning highlights the severe health implications that could arise from ingesting the contaminated antihistamine, underscoring the importance of consumer awareness and adherence to recall notices for public safety. Further details regarding the specific lot numbers and distribution channels are available through the FDA's recall information channels.