The U.S. Food and Drug Administration (FDA) is warning individuals to steer clear of select antihistamine tablets due to the fact that the tablets may be cross-contaminated with an ulcer-treating drug that can cause “serious adverse events”—including life-threatening ones—in people who are hypersensitive to the ingredients. Here’s what you need to know.
What’s happened?
This week, FDA published a recall notice for a voluntary recall that Unique Pharmaceutical Laboratories initiated over the weekend for certain lots of its Cetirizine Hydrochloride Tablets USP—specifically, 5 mg antihistamine tablets.
The tablets are commonly used to treat allergy symptoms, including sneezing, runny nose, and red, itchy, or watery eyes, according to MedlinePlus.
At issue with the recalled tablets is the fact that they may be cross-contaminated with a medication called Ranitidine. Ranitidine is commonly used to treat ulcers, gastroesophageal reflux disease (GERD), and other issues related to stomach acid, according to MedlinePlus.
Unfortunately, individuals who are hypersensitive to the ingredients in Ranitidine can experience “serious adverse events” if the medication is ingested, says the FDA.
These adverse events include “severe hypersensitivity reactions and anaphylaxis that manifests as hypotension, dyspnea, difficulty swallowing, throat and facial edema, generalized pruritic, urticaria, and loss of consciousness.”
The agency adds that all of these adverse events are “life-threatening.”
The potential cross-contamination was noticed after a pharmacy technician identified a discrepancy with the tablets while counting them as they were dispensing them, according ot the recall notice.
After looking into the report, Unique Pharmaceuticals notified its distributor, Rising Pharma Holdings, and initiated the voluntary recall.
What products are recalled?
Four lots of the tablets are being recalled. All are packaged in HDPE Bottle packs of 100 tablets (NDC: 16571-401-10).
- Product Description: Cetirizine Hydrochloride Tablets USP 5 mg, Pack 100’s HDPE container
- NDC: 16571-401-10
- Manufacturer: Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.)
- Distributed By: Rising Pharma Holdings Inc.
- Expiration Date: 10/2028
- Lot Numbers: GY825029, GY825030, GY825031, GY825032
You can view images of the recalled tablets and product packaging here.
Has anyone been harmed by the recalled tablets?
As of the recall notice date, Unique Pharmaceutical Laboratories said it had not received any reports of anyone suffering adverse events related to the recalled tablets.
Where were the recalled products sold?
The recall notice does not list exact stores or pharmacies where the product was sold, but the notice states that the “Product was distributed Nationwide to several wholesalers/retailers.”
What should I do if I have the recalled products?
The recall notice states that consumers with general or medical questions about the recall should contact Rising Pharma Holdings Inc. The phone number is 1-844-874-7464 and the email addresses are pv@risingpharma.com and qa@risingpharma.com.
“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,” the notice states.
Consumers should read the full recall notice here for complete details.
