Cetirizine Recall Issued Over Heartburn Drug Contamination Risk

A cetirizine antihistamine recall has been issued nationwide due to potential cross-contamination with ranitidine, a heartburn medication.

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A generic version of Zyrtec has been voluntarily recalled across the United States due to potential contamination with ranitidine, a heartburn medication, the FDA announced. The affected cetirizine hydrochloride tablets were distributed by Rising Pharma Holdings to retailers nationwide. While no adverse events have been reported, consumers with hypersensitivity to ranitidine ingredients could experience severe, potentially life-threatening reactions.

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How the Contamination Was Discovered

A pharmacy technician identified the contamination issue while counting and bottling the antihistamine medication. The technician observed red dots on some cetirizine tablets and noted discoloration on others, which prompted an investigation. This observation by the pharmacist led manufacturer Unique Pharmaceutical Laboratories to announce the voluntary recall on July 18.

Health Risks and Affected Products

According to the FDA, consumers exposed to ranitidine-contaminated cetirizine tablets face a "reasonable probability" of serious adverse events. Potential reactions include hypotension, severe shortness of breath, difficulty swallowing, throat and facial swelling, generalized itching and hives, and loss of consciousness. The recalled 5-milligram cetirizine hydrochloride tablets are packaged in 100-tablet bottles with an expiration date of October 2028.

Rising Pharma Holdings has notified its customers and is coordinating the return of all recalled medications. The company distributed the affected products to multiple retailers and wholesalers throughout the nation. Consumers can contact Rising Pharma Holdings at 1-844-874-7464 or via email at pv@risingpharma.com or qa@risingpharma.com for information about specific lot numbers under recall.

Patients who have purchased affected cetirizine bottles are advised to check the product labels for the recalled lot numbers before use. Healthcare providers encourage anyone experiencing adverse reactions after consuming potentially contaminated medication to seek immediate medical attention. Those with questions about whether their medication is affected should contact their pharmacy or Rising Pharma Holdings directly.

What is cetirizine, and what is it used for?+
Cetirizine is an antihistamine commonly sold under the brand name Zyrtec. It is used over-the-counter to treat seasonal allergies and allergy symptoms including sneezing, runny nose, and itchy eyes.
How do I know if my cetirizine tablets are part of the recall?+
Check your cetirizine bottle for the product name, manufacturer details, and lot number. Products set to expire in October 2028 with specific lot numbers are under recall. Rising Pharma Holdings can provide the complete list of affected lot numbers when contacted at 1-844-874-7464.
What are the symptoms of a severe ranitidine hypersensitivity reaction?+
Severe reactions may include low blood pressure, difficulty breathing, throat swelling, facial swelling, severe itching, hives, and loss of consciousness. Any of these symptoms warrant immediate emergency medical care.
Has anyone been harmed by the contaminated cetirizine tablets?+
According to the FDA, there have been no reports of adverse events related to the recall as of the announcement. However, the recall was issued proactively due to the serious potential health risks posed by ranitidine contamination.

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