A generic model of the brand-name allergy treatment Zyrtec is beneath recall across the U.S. as a result of potential cross-contamination with a heartburn drug, in line with the Food and Drug Administration.
Drugmaker Unique Pharmaceutical Laboratories is voluntarily recalling antihistamine medicine, generally used to deal with seasonal allergic reactions, over potential cross-contamination with ranitidine, a heartburn drug. Unique Pharmaceutical Laboratories introduced the recall on July 18.
A pharmacy technician noticed what they described as a crimson dot on a few of the antihistamine medicine — cetirizine hydrochloride tablets USP 5 mg — when counting and bottling the medicines, in line with the FDA’s recall notice. Other tablets had been discolored, alerting the technician to a doable concern.
The FDA indicated that customers who’re hypersensitive to components contained in ranitidine might expertise adversarial unwanted side effects upon publicity, together with hypotension, shortness of breath, issue swallowing, lack of consciousness and different life-threatening reactions.
There have been no experiences of adversarial occasions associated to the recall, in line with the FDA.
What merchandise are affected?
The tablets, distributed by Rising Pharma Holdings Inc. to retailers across the U.S., are packaged in 100-tablet bottles. Products with the following lot numbers, set to run out in October 2028, are beneath recall:
- GY825029
- GY825030
- GY825031
- GY825032
Rising Pharmaceutical Holdings has notified its clients about the recall and is arranging for the return of all medicine which might be beneath recall.
Consumers with questions can contact Rising Pharma Holdings straight at 1-844-874-7464, or by electronic mail at pv@risingpharma.com or qa@risingpharma.com. Patients are inspired to succeed in out to their healthcare supplier in the event that they expertise issues associated to the doubtlessly contaminated medicine.