Urgent Recall: Allergy Medication Linked to Potentially Life-Threatening Cross-Contamination

(NEXSTAR) – An urgent recall has been issued for several batches of a popular allergy medication after it was potentially mixed with a different drug, posing a risk of life-threatening reactions for certain users.

The U.S. Food and Drug Administration has reported that Unique Pharmaceutical Laboratories is voluntarily recalling four lots of cetirizine hydrochloride tablets due to the risk of cross-contamination.

Cetirizine hydrochloride, a widely used allergy medicine, is effective in alleviating symptoms such as sneezing, a runny or itchy nose, itchy throat, and irritated eyes, according to Medline Plus.

The contamination was suspected to involve ranitidine, an antihistamine that the Cleveland Clinic notes is often utilized to reduce stomach acid production in cases of ulcers or heartburn.

However, some consumers may be hypersensitive to the ingredients in ranitidine, the recall notice explains. They may experience “serious adverse events, including severe hypersensitivity reactions and anaphylaxis.” This could lead to low blood pressure, difficulty breathing or swallowing, swelling in the throat and face, itchy skin, hives, or even loss of consciousness, “which are all life-threatening.”

A pharmacy technician reportedly discovered the issue, noting a red dot on the cetirizine hydrochloride tablets and others that were discolored.

There have been no reported adverse incidents reported as a result of the medication, the recall notice says.

The recalled medication was distributed in 100-tablet bottles nationwide by Rising Pharma Holdings Inc. The below table outlines which bottles of the tablets have been recalled:

The company has already contacted customers who were impacted by email to arrange returns. If you have any questions, you can contact Rising Pharma Holdings at 1-844-874-7464 during business hours, or via email at pv@risingpharma.com or qa@risingpharma.com.

In 2020, the FDA called for ranitidine to be removed from the market amid a safety investigation. Some products were found to have low levels of N-Nitrosodimethylamine, or NDMA, which can cause cancer. Last year, a reformulated ranitidine tablet was approved by the FDA, marking its return.