Unique Pharmaceutical Laboratories has initiated a voluntary recall of four lots of its Cetirizine Hydrochloride Tablets USP 5 mg due to cross-contamination with ranitidine, a medication used to treat stomach acid ailments. The U.S. Food and Drug Administration (FDA) announced the recall, highlighting that the contamination poses a potentially life-threatening risk to individuals with severe allergies or anaphylaxis to certain ingredients.
The recall, announced by the company on July 18 and posted by the FDA, affects product in an HDPE Bottle pack containing 100 tablets, identified by NDC: 16571-401-10. According to the FDA's risk statement, individuals with a hypersensitivity to ranitidine who ingest the contaminated cetirizine could experience severe hypersensitivity reactions and anaphylaxis. Symptoms may include hypotension, dyspnea, difficulty swallowing, throat and facial edema, generalized pruritic, urticaria, and loss of consciousness.
Unique Pharmaceutical Laboratories, a division of J. B. Chemicals & Pharmaceuticals Ltd., reported that the issue was discovered when a product complaint indicated a discrepancy noticed by a pharmacy technician. The complaint described tablets with a red dot appearance and some discolored tablets due to multiple red-colored dots.
To date, Unique Pharmaceuticals has not received any reports of adverse events linked to this recall. The company has notified its distributor, Rising Pharma Holdings Inc., which is in turn notifying its distributors and customers and arranging for the return of all recalled products.
Consumers experiencing adverse reactions or quality problems with this product are encouraged to report them to the FDA's MedWatch Adverse Event Reporting program online, by mail, or by fax. More details regarding the NDC, manufacturer, distributor, product design, lot numbers, and expiration dates of the affected products are available on the FDA's recall notice.