Rising Pharma Holdings Inc. has issued an urgent recall for certain lots of 5-mg cetirizine hydrochloride tablets after the medication may have been cross-contaminated with ranitidine, a drug used to treat heartburn. The U.S. Food and Drug Administration (FDA) announced that consuming the contaminated tablets could lead to anaphylaxis in people with a hypersensitivity to ranitidine ingredients.
Recall details
The New Jersey-based pharmaceutical company recalled four lots of the antihistamine on July 18. The tablets were manufactured by Unique Pharmaceutical Laboratories, an Indian company, and were distributed nationwide in the United States in bottles of 100.
The recall was prompted after a pharmacy technician noticed a red dot on some tablets during counting. The FDA stated that the cross-contamination may have occurred with ranitidine, which decreases stomach acid production.
Affected lot numbers
The recalled bottles carry the National Drug Code 16571-401-10 and expiration date of October 2028. The affected lot numbers are GY825029, GY825030, GY825031, and GY825032.
Consumer guidance
Although no adverse reactions have been reported so far, Rising Pharma warned that customers with a sensitivity to ranitidine could experience serious adverse events, including anaphylaxis. The company advised: “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.”
Anyone who suffers an adverse reaction can report it to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov.
