A nationwide recall has been issued for four lots of Cetirizine Hydrochloride Tablets USP 5 mg after the manufacturer discovered potential cross-contamination with ranitidine, according to the U.S. Food and Drug Administration (FDA).
Unique Pharmaceutical Laboratories, a division of J. B. Chemicals & Pharmaceuticals Ltd., voluntarily recalled the affected products to the consumer level after receiving a complaint about discolored tablets.
The recalled medication is distributed nationwide by Rising Pharma Holdings Inc. and is commonly used as an antihistamine to treat allergy symptoms.
Why the Tablets Are Being Recalled
According to the FDA, the recall was initiated because some Cetirizine tablets may be contaminated with ranitidine.
The issue came to light after a pharmacy technician noticed tablets with red discoloration while counting medication for dispensing. The complaint described tablets with multiple, red-colored dots and an abnormal appearance.
Although no illnesses or injuries have been reported, the manufacturer said the contamination poses a potentially serious health risk for individuals who are hypersensitive to ingredients found in ranitidine.
Potential Health Risks
The FDA warns that people with hypersensitivity to ranitidine ingredients could experience severe allergic reactions after taking contaminated tablets.
Possible symptoms include:
- Low blood pressure (hypotension).
- Difficulty breathing (dyspnea).
- Difficulty swallowing.
- Swelling of the throat or face.
- Severe itching.
- Hives (urticaria).
- Loss of consciousness.
The agency said these reactions can be life-threatening and require immediate medical attention.
As of the recall announcement, Unique Pharmaceutical Laboratories said it had not received any reports of adverse events related to the recalled product.
Recalled Product Information
The recall affects the following product:
Product: Cetirizine Hydrochloride Tablets USP 5 mg
Package: 100-count HDPE bottle
NDC: 16571-401-10
Distributed by: Rising Pharma Holdings Inc.
Affected lot numbers:
- GY825029
- GY825030
- GY825031
- GY825032
Expiration date: October 2028
The affected products were distributed nationwide to wholesalers and retailers.
What Consumers Should Do
Consumers who have the recalled medication should check the lot number on their bottle to determine whether it is included in the recall.
Anyone who experiences symptoms or health problems after taking the medication should contact their physician or health care provider immediately.
Consumers with questions about the recall may contact Rising Pharma Holdings Inc. by:
- Phone: 1-844-874-7464 (Monday through Friday, 8 a.m. to 5 p.m. EST)
- Email: [email protected] or [email protected]
Health care professionals and consumers are also encouraged to report adverse events or product quality issues to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
