FDA Recalls Antihistamine Tablets Due to Heartburn Drug Contamination

A voluntary recall of generic antihistamine tablets, commonly used for seasonal allergies, is underway across the United States due to concerns of potential cross-contamination with a heartburn medication. Drugmaker Unique Pharmaceutical Laboratories announced the recall on July 18, affecting cetirizine hydrochloride tablets USP 5 mg.

The issue came to light when a pharmacy technician observed a red dot on some tablets while counting and bottling the medication. Further inspection revealed other tablets were discolored, prompting the technician to alert authorities to a possible problem. The U.S. Food and Drug Administration (FDA) has been notified of the recall.

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The FDA indicated that consumers who are hypersensitive to ingredients contained in ranitidine could experience adverse side effects upon exposure, including hypotension, shortness of breath, difficulty swallowing, loss of consciousness and other life-threatening reactions.

According to the FDA's recall notice, consumers who are hypersensitive to ingredients found in ranitidine, a heartburn drug, could face adverse side effects if exposed. These reactions might include hypotension, shortness of breath, difficulty swallowing, and even loss of consciousness, potentially leading to life-threatening situations. However, the FDA has stated that there have been no reported adverse events linked to this specific recall.

The affected products are packaged in 100-tablet bottles and were distributed by Rising Pharma Holdings Inc. to retailers nationwide. Consumers are advised to check for specific lot numbers (GY825029, GY825030, GY825031, GY825032) and an expiration date of October 2028. Rising Pharma Holdings has informed its customers and is coordinating the return of the recalled drugs. Patients experiencing issues are encouraged to contact their healthcare provider.

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There have been no reports of adverse events related to the recall.