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Four lots of a prescription antihistamine have been recalled because the tablets might be “contaminated” with a different prescription antihistamine.
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Unique Pharmaceutical Laboratories pulled lot Nos. GY825029, GY825030, GY825031 and GY825032 of 100-count bottles of Cetirizine Hydrochloride 5 mg because the tablets might have ranitidine.
“For consumers with a hypersensitivity to the ingredients in ranitidine,” the company recall notice said, “there is a reasonable probability that ingestion of cetirizine tablets contaminated with ranitidine could result in serious adverse events including severe hypersensitivity reactions and anaphylaxis that manifests as hypotension, dyspnea, difficulty swallowing, throat and facial edema, generalized pruritic, urticaria, and loss of consciousness, which are all life-threatening.”
Ranitidine was sold over-the-counter under the brand name Zantac. Cetrizine is the generic version of Zyrtec.
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According to the company-written, FDA-posted recall notice, a pharmacy technician saw the problem while counting Cetirizine Hydrochloride tablets. The tablets “appeared as discolored due to multiple red colored dots on the tablets.”
If you have a medical problem, see a medical professional. Then, contact the FDA’s MedWatch Adverse Event program through their online portal.
Direct questions about this recall to East Brunswick, New Jersey’s Rising Pharma Holdings at [email protected], [email protected] or 844-874-7464, Monday through Friday, from 8 a.m. to 5 p.m., Eastern time.
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