A nationwide recall has been issued for certain bottles of cetirizine hydrochloride tablets after the drug was found to be at risk of contamination with another drug that may lead to serious allergic reactions in some patients.
New Jersey-based Rising Pharma Holdings Inc. announced the voluntary recall on July 18, affecting nearly four lots of its 5mg cetirizine hydrochloride drugs, a commonly used antihistamine for treating seasonal allergies and hives.
The drug was manufactured by Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd. in India, before being distributed across the US.
Why the medication is being recalled?
As per the recall notice published by the US Food and Drug Administration (FDA), the affected lot has been cross-contaminated with ranitidine, a drug used for the treatment of heartburn, and acidity.
Notably, no side effects have been reported yet.
Affected products
The recall applies to 100-count bottles of cetirizine hydrochloride tablets with these details:
National Drug Code (NDC): 16571-401-10
Expiration date: October 2028
Lot numbers: GY825029, GY825030, GY825031 and GY825032
The recalled products were distributed nationwide to wholesalers and retail pharmacies.
People who are sensitive to ranitidine may develop severe allergic reactions, such as anaphylaxis, a life-threatening condition that may pose a significant threat on your health.
Symptoms include dysphagia, apnea, hypotension, swelling of the throat, face or beneath the skin, hives, itching, and more issues.
Advise for consumers
To avoid these reactions, consumers are urged to check the lot number on their medicine bottles to stop using them.
For questions regarding the recall, customers can contact Rising Pharma Holdings Inc. by phone at 1-844-874-7464 during business hours or email pv@risingpharma.com or qa@risingpharma.com.
