Bottles of recalled Cetirizine Hydrochloride Tablets USP 5 mg, distributed by Rising Pharma Holdings Inc. and manufactured by Unique Pharmaceutical Laboratories, are shown. (Credit: FDA)
Unique Pharmaceutical Laboratories, a division of J. B. Chemicals & Pharmaceuticals Ltd., is voluntarily recalling four lots of Cetirizine Hydrochloride Tablets USP 5 mg after discovering the allergy medication may be cross-contaminated with ranitidine, according to the U.S. Food and Drug Administration.
Dig deeper:
The nationwide recall affects 100-count HDPE bottles of the antihistamine distributed by Rising Pharma Holdings Inc.
The company said the recall was initiated after a pharmacy technician noticed unusual tablets while dispensing the medication
A product complaint described tablets with red dots and discoloration, leading to the discovery of cross-contamination with ranitidine.
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Why you should care:
According to the company, consumers who are hypersensitive to ranitidine ingredients face a risk of serious allergic reactions if they take the contaminated tablets.
Potential reactions include anaphylaxis, low blood pressure, difficulty breathing, trouble swallowing, swelling of the face and throat, widespread itching, hives and loss of consciousness.
The company said these reactions can be life-threatening.
Unique Pharmaceuticals said it has not received any reports of adverse events related to the recall.
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The recalled product is Cetirizine Hydrochloride Tablets USP 5 mg (NDC 16571-401-10), packaged in 100-count HDPE bottles. The affected lot numbers are GY825029, GY825030, GY825031 and GY825032, all with expiration dates of October 2028. The products were distributed nationwide to wholesalers and retailers.
Rising Pharma Holdings has notified distributors and direct customers by email and is arranging for the return of all recalled products.
What you can do:
Consumers with questions about the recall can contact Rising Pharma Holdings at 1-844-874-7464, Monday through Friday from 8 a.m. to 5 p.m. EST, or by email at pv@risingpharma.com or qa@risingpharma.com. Anyone who experienced health problems after taking the medication should contact a physician or healthcare provider.
Consumers can also report adverse reactions or product quality issues through the FDA's MedWatch Adverse Event Reporting Program online, by mail or by fax.
The recall is being conducted with the knowledge of the FDA.