If you take an antihistamine for seasonal allergies, check your medicine cabinet ASAP. There’s a nationwide recall of one such product, and it’s important to know if you have it or have used it.
On July 20, the U.S. Food and Drug Administration (FDA) reported a voluntary recall of Cetirizine Hydrochloride Tablets USP 5 mg—a generic version of Zyrtec—by its manufacturer, Unique Pharmaceutical Laboratories. The tablets were distributed to U.S. retailers by Rising Pharma Holdings Inc.
Why is the antihistamine being recalled?
The reason for the recall is that the tablets were potentially cross-contaminated with a heartburn drug called Ranitidine. Ranitidine is also known by the brand names Zantac and Tritec. In addition to heartburn, it’s used to treat GERD and ulcers.
According to the FDA, the problem was discovered by a pharmacy technician who was counting out the allergy tablets to disperse them. The technician noticed that some of the tablets had a red dot that was not supposed to be on them, and that other tablets were discolored due to multiple red dots.
What is the health risk if you take one of the cross-contaminated tablets?
So far, no adverse events have been reported by any consumers. However, if you have a hypersensitivity to Ranitidone, the FDA says that there’s a “reasonable probability” you could suffer adverse side effects if you take a Cetirizine Hydrochloride USP 5 mg tablets from a cross-contaminated batch. These side effects include severe hypersensitivity reactions and anaphylaxis that cause hypotension, dyspnea, difficulty swallowing, throat and facial edema, generalized pruritic, urticaria, and loss of consciousness, which are all life-threatening.
“The onset and intensity of adverse effects, associated with the use of antihistamine agents Zyrtec and Ranitidine, are highly variable depending on a person’s age, medication dosage, individual sensitivity to the chemical compound, and your baseline liver or kidney function,” says Irakli Todua, MD ,an internal medicine physician at Tufts Medical Center in Boston. “The first symptoms, such as abdominal pain or dry mouth, tend to appear within 1 to 2 hours, whereas cardiovascular or sedative affects, such as low blood pressure and heart rate, drowsiness or agitation, tend to be delayed by several hours. There aren’t any antidotes you could use at home. Immediately call your doctor’s office or 911 if you suspect you’re having adverse effects.”
How do you know if you have the recalled antihistamine?
The tablets are packaged in 100-count HDPE (high-density polyethylene, a type of plastic) bottles. Look on the label for the following affected lot numbers:
- GY825029
- GY825030
- GY825031
- GY825032
All affected bottles have an expiration date of October 2028.
What do you do if you have the recalled antihistamine?
First of all: don’t take the meds, and if you have taken them already, call your doctor, even if you feel fine. Seek medical advice about potential symptoms and find out if your doctor wants to see you, just to be on the safe side.
You can also contact Rising Pharma Holdings directly at 1-844-874-7464 (Monday to Friday, 8AM to 5PM EST), or by email at [email protected] or [email protected] if you have questions. The company hasn’t released specific information about refunds, but says it’s arranging for all affected bottles to be returned.
The FDA also encourages consumers to report any adverse reactions to this product to its MedWatch Adverse Event Reporting program. You can complete a report online or send it in via regular mail or fax.
