The Food and Drug Administration (FDA) this week upgraded a recall of a type of antihistamine to its most severe level due to cross-contamination.
JB Chemicals and Pharmaceuticals Ltd. of India is recalling several lots of cetirizine hydrochloride tablets in 5-milligram doses, according to a notice published by the FDA, updated Aug. 3. The action impacts 34,020 100-count bottles nationwide, it said.
There were “customer complaints for appearance of discolored tablets and red dots observed on” the cetirizine tablets. It was determined to be ranitidine, a medication that is primarily used to treat heartburn, ulcers, and acid reflux disease.
Consumers who have a heightened sensitivity to ranitidine, JB Chemicals said, may see a “reasonable probability that ingestion of cetirizine tablets contaminated with ranitidine could result in serious adverse events including severe hypersensitivity reactions and anaphylaxis.”
Symptoms can include “hypotension, dyspnea (shortness of breath), difficulty swallowing, throat and facial edema, generalized pruritic urticaria (itchy hives), and loss of consciousness, which are all life-threatening,” the company said.
The recalled medication is packaged in a bottle pack with 100 tablets and has a National Drug Code (NDC) of 16571-401-10, according to the notice. The recalled medication has an expiration date of October 2028 and lots of GY825029, GY825030, GY825031, and GY825032.
The FDA on Aug. 3 classified the recall as Class I, or its more serious designation. The agency says it is “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Separately, the FDA says such recalls are deemed by the agency to be “the most serious,” noting that potential health consequences for a patient using the medication could be “immediate and life threatening.”
“A Class I recall is urgent and generally involves removing the drug from the market. These recalls are generally conducted at the consumer level,” the agency says.
Cetirizine hydrochloride, sometimes sold under the Zyrtec brand, is used to relieve seasonal allergy symptoms, allergic rhinitis, and hives. Ranitidine works by blocking histamine-2 receptors in the stomach, which decreases the volume and acidity of gastric secretions.
JB Chemicals, the manufacturer of the drug, recalled the medication on June 24. The FDA notice this week did not specify whether consumers should discard and stop using the medication.
