U.S. — Unique Pharmaceutical Laboratories initiated a voluntary recall of cetirizine hydrochloride tablets USP 5 mg on July 18. The recalled cetirizine hydrochloride tablets may be cross-contaminated with ranitidine.

The recalled lots are GY825029, GY825030, GY825031, and GY825032. The recalled lots have an expiration date of October 2028.

A pharmacy technician observed red dots or discoloration on some cetirizine hydrochloride tablets while counting and bottling the medications. The recalled tablets are packaged in 100-tablet high-density polyethylene (HDPE) bottles. The recalled products have the National Drug Code (NDC) 16571-401-10.

Unique Pharmaceuticals notified Rising Pharma Holdings Inc. of the recall. Rising Pharma Holdings Inc. notified its customers about the recall. Rising Pharma Holdings Inc. is arranging for the return of all recalled drugs.

Rising Pharma Holdings Inc., a pharmaceutical company, advised consumers on the necessary steps. Rising Pharma Holdings Inc. said consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Patients are encouraged to reach out to their healthcare provider if they experience problems related to the potentially contaminated drugs.

The FDA stated that consumers hypersensitive to ingredients in ranitidine could experience adverse side effects upon exposure, including hypotension, shortness of breath, difficulty swallowing, and loss of consciousness. The FDA stated that anaphylaxis symptoms from exposure to ranitidine may include hypotension, difficulty breathing, difficulty swallowing, swelling of the throat or face, intense itching, hives, and loss of consciousness.

Unique Pharmaceutical Laboratories has not received any reports of adverse events associated with the recall. Ranitidine was removed from the U.S. market in 2020 after regulators raised concerns over contamination with a probable human carcinogen. Cetirizine hydrochloride tablets are commonly sold over the counter as generic versions of Zyrtec.

Consumers can contact Rising Pharma Holdings Inc. by email at pv@risingpharma.com or qa@risingpharma.com. Consumers can contact Rising Pharma Holdings Inc. at 1-844-874-7464 from 8 a.m. to 5 p.m. ET, Monday through Friday, for questions about the recall. Customers can report adverse reactions or quality problems to the FDA's MedWatch Adverse Event Reporting program by submitting a report at www.fda.gov.

The voluntary recall addresses potential cross-contamination with ranitidine, a medication removed from the U.S. market in 2020 due to concerns over contamination with a probable human carcinogen. The FDA outlined specific anaphylaxis symptoms and adverse side effects for consumers hypersensitive to ranitidine ingredients, including hypotension, difficulty breathing, and loss of consciousness.

Rising Pharma Holdings Inc., the New Jersey-based distributor, is coordinating the return of all recalled drugs and has notified its customers across the United States. While Unique Pharmaceutical Laboratories reported no adverse events, the distributor provided multiple contact methods, including email addresses and a toll-free phone number, for consumers with questions or concerns about the affected lots.