Bottles of antihistamine tablets recalled. See the affected products - USA Today

What the report says

USA Today reported that Rising Pharma Holdings Inc., a New Jersey-based pharmaceutical company, has recalled four lots of cetirizine hydrochloride 5 mg tablets after a possible contamination issue. The recall was issued July 18 and involves 100-count bottles of the antihistamine, which is commonly used for seasonal allergy symptoms and hives.

According to an announcement posted on the U.S. Food and Drug Administration’s website and cited by USA Today, the tablets were manufactured by Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd. in India, and distributed by Rising Pharma Holdings. The products may have been cross-contaminated with ranitidine, a medicine used for heartburn, acid indigestion and sour stomach. The issue was noticed after a pharmacy technician saw red dots on some tablets while counting them.

The recalled bottles carry National Drug Code 16571-401-10, an expiration date of October 2028 and lot numbers GY825029, GY825030, GY825031 and GY825032. USA Today reported that the product was distributed nationwide to wholesalers and stores. The article said the number of bottles affected was not yet available; Rising Pharma had not immediately responded to USA Today’s July 21 request for that figure.

No adverse reactions had been reported to Unique Pharmaceutical Laboratories at the time of the FDA-posted notice, according to USA Today. However, the company warned that people sensitive to ranitidine ingredients could face serious reactions, including anaphylaxis. Consumers with questions were directed to Rising Pharma by phone at 1-844-874-7464 or by email, and those with medical concerns were advised to contact a health care provider and report problems to the FDA’s MedWatch program.