A recall notice published by the Food and Drug Administration said that a prescription antihistamine is under recall due to possible cross-contamination that could result in “serious adverse events.”
Unique Pharmaceutical Laboratories of Gujarat, India, said in the notice that it is initiating the voluntary recall of four lots of cetirizine hydrochloride tablets in 5-milligram doses that were distributed at the consumer level due to contamination with ranitidine, a medication that is primarily used to treat heartburn, ulcers, and acid reflux disease.
Among consumers who have a heightened sensitivity to ranitidine, the firm said, “there is a reasonable probability that ingestion of cetirizine tablets contaminated with ranitidine could result in serious adverse events including severe hypersensitivity reactions and anaphylaxis.”
That can show as “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.
No reports of adverse events in connection with the recalled products have been reported to date, it said.
The cetirizine hydrochloride is packaged in a bottle pack with 100 tablets and has a National Drug Code of 16571-401-10, the company said. The recalled medication has expiration dates of October 2028 and lots of GY825029, GY825030, GY825031, and GY825032.
A pharmacy technician said that the contamination was discovered while counting tablets while they were being dispensed, when there was a product complaint report about a “red dot” appearing on the cetirizine tablets and that some were reported as discolored “due [to] multiple red colored dots on tablets,” according to the company.
The company did not specify whether the cetirizine tablets themselves were mixed with ranitidine, or whether ranitidine tablets or pills were mixed into the lots of cetirizine.
The FDA did not classify the recall, while Unique Pharmaceutical Laboratories did not say how many bottles of the medication were impacted. The company also did not specify whether consumers should discard and stop using the medication.
Consumers who are concerned about the recalled product are advised to contact Rising Pharma Holdings Inc., the company said, adding that people who may be experiencing health problems related to the recalled product should communicate with their physician or healthcare provider.
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.
A report published in the National Institutes of Health in 2015 suggested that cetirizine and ranitidine can be taken together. “Combination of cetirizine with ranitidine was not more effective than cetirizine alone in chronic urticaria. Both treatments [were] equally safe,” it said.
Earlier this month, 9,048 bottles of a different antihistamine medication, fexofenadine hydrochloride tablets that were made by Indian drug giant Sun Pharmaceutical Industries, were recalled across the United States, according to an FDA notice. The medication was recalled after failing a test.
Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals, a major Indian pharmaceutical company, did not immediately respond to a request for comment Wednesday.