The antihistamine has been recalled by the pharmaceutical company due to risk of contamination.
New Jersey-based pharmaceutical company Rising Pharma Holdings Inc. recalled the tablets on July 18.
The recall was made for four lots of 5-milligram cetirizine hydrochloride tablets, used to treat seasonal allergies and hives.
An Indian based company, Unique Pharmaceutical Laboratories, manufactured the medication according to the Food and Drug Administration.
The medication was stocked and sold nationwide in the US.
The cetirizine hydrochloride tablets may have been cross-contaminated with ranitidine, which is used to treat heartburn, acid indigestion and sour stomach, according to the companies.
Ranitidine decreases the amount of acid made in the stomach.
The FDA’s website states that there may have been an issue with the tablet when a pharmacy technician was counting tablets and saw a red dot on some of them.
The cetirizine hydrochloride tablets being recalled are sold in bottles of 100.
The contaminated bottles have the following information:
Although there are currently no reports of adverse reactions to the cetirizine hydrochloride tablets, customers with a hypersensitivity to the ingredients in ranitidine could experience “serious adverse events”, according to the announcement.
Customers who have a sensitivity to ranitidine and ingest the tablets may suffer anaphylaxis.
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.”
Customers who suffer adverse reactions can report them to the FDA’s MedWatch Adverse Event Reporting program by completing and submitting a report at www.fda.gov.