Key Takeaway:
- The FDA cetirizine recall affects four nationwide lots of cetirizine tablets due to possible contamination with ranitidine, which may trigger life-threatening allergic reactions in sensitive individuals.
- The issue was discovered after a pharmacy technician noticed red dots and discoloration on some tablets before dispensing.
- No adverse events have been reported, but consumers should check affected lot numbers and stop using recalled products.
The U.S. Food and Drug Administration says four lots of cetirizine hydrochloride tablets are being recalled nationwide after potential contamination with ranitidine, which could trigger life-threatening allergic reactions in susceptible consumers.
FDA Warns Consumers About Contaminated Allergy Medication
The FDA cetirizine recall covers four lots of 5-milligram cetirizine hydrochloride tablets manufactured by Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., and distributed by Rising Pharma Holdings Inc.
According to the FDA, the voluntary recall was announced after the tablets were found to have potential cross-contamination with ranitidine, a medication used to treat heartburn and stomach ulcers. The agency says consumers who are hypersensitive to ingredients in ranitidine face a risk of severe allergic reactions, including anaphylaxis.
The FDA cetirizine recall applies to products that were distributed nationwide in 100-count bottles to wholesalers and retailers. The affected bottles carry National Drug Code 16571-401-10, an expiration date of October 2028, and lot numbers GY825029, GY825030, GY825031 and GY825032.
Pharmacy Discovery Triggers Nationwide Recall
The issue behind the FDA cetirizine recall came to light after a pharmacy technician noticed unusual red dots on some tablets while counting medication before dispensing it to a patient.
Some tablets also showed discoloration caused by multiple red dots, prompting further investigation and the voluntary recall.
“Consumers with a hypersensitivity to the ingredients in ranitidine have a reasonable probability of experiencing serious adverse events, including severe hypersensitivity reactions and anaphylaxis,” the FDA said in its recall notice.
Despite the potential risk, Unique Pharmaceutical Laboratories says it has not received any reports of adverse events linked to the recalled tablets.
Rising Pharma has notified distributors and direct customers by email and is arranging the return of all recalled products, according to the FDA.
Consumers Advised to Stop Using Affected Lots
Cetirizine is the generic form of the allergy medication Zyrtec and is commonly used to prevent and treat seasonal allergy symptoms. Ranitidine reduces stomach acid production and has been used to treat acid reflux and ulcers.
The FDA advises consumers to identify affected bottles by checking the lot number, manufacturer information, and expiration date. Anyone who believes they possess recalled tablets should stop using the medication and contact a health care provider if they experience symptoms or have medical concerns.
Consumers with questions about the FDA cetirizine recall can contact Rising Pharma Holdings Inc. during business hours. The FDA also encourages patients and health care professionals to report suspected adverse reactions through the agency’s MedWatch Adverse Event Reporting Program.
PEOPLE magazine said it requested comment from Rising Pharma Holdings Inc. and J.B. Chemicals & Pharmaceuticals Ltd., but no response had been reported at the time of publication.
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