Popular allergy medication recalled over potentially ‘life-threatening’ cross-contamination

Digital Editor

A popular allergy medication has been recalled over contamination concerns, potentially leading to life-threatening side effects.

Unique Pharmaceutical Laboratories has recalled four lots of cetirizine hydrochloride tablets, an antihistamine commonly sold over the counter as a generic version of Zyrtec.

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According to a release from the U.S. Food and Drug Administration, the medication may be cross contaminated with ranitidine, used to treat heartburn and acid indigestion.

“For consumers with a hypersensitivity to the ingredients in ranitidine, 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,” the FDA said in a statement.

To date, there have been no reports of adverse events related to the recall, officials said.

The affected products were sold in bottles labeled “Original Prescription Strength Cetirizine Hydrochloride Tablets USP.” Each contains 100 5-mg tablets, according to the recall, under the National Drug Code (NDC) 16571-401-10.

All of the recalled products have an expiration date of October 2028.

Four manufacturing lots are listed in the recall, GY825029, GY825030, GY825031 and GY825032.

The label of the recalled medication and where to find the Lot No.

The recalled products were distributed nationwide to retailers and wholesalers, FDA officials said. Unique Pharmaceuticals has notified its distributor Rising Pharma Holdings Inc. of the recall.

For more information on the recall, click here.