Unique Pharmaceutical Laboratories recalled cetirizine hydrochloride tablets USP 5 mg across the U.S. on July 18 after a pharmacy technician saw a red dot on some bottles and found other tablets discolored. The antihistamine, a generic version of Zyrtec, was packaged in 100-tablet bottles. Rising Pharma Holdings Inc. is arranging returns for the recalled product.
July 18 recall notice
The recall covers tablets distributed to retailers across the U.S. and affects products packaged in 100-tablet bottles. Unique Pharmaceutical Laboratories said the problem involved possible cross-contamination with ranitidine, a heartburn drug. A pharmacy technician noticed the issue while counting and bottling the medications, which gave the company the first visual warning that some lots may not have been uniform.
Rising Pharma Holdings Inc. recalls four lots in Cetirizine Recall This recall matters to consumers who bought the medicine for allergy symptoms and may still have unopened bottles at home. The product name, strength and package size are the practical identifiers people need to check before using any tablets.
FDA risk warning
The FDA said consumers who are hypersensitive to ingredients contained in ranitidine could experience adverse side effects if exposed. The agency listed hypotension, shortness of breath, difficulty swallowing, loss of consciousness and other life-threatening reactions. There have been no reports of adverse events related to the recall.
Rising Pharmaceutical Holdings has notified customers and is arranging for the return of all drugs under recall. Consumers with questions can contact Rising Pharma Holdings at 1-844-874-7464, [email protected], or [email protected]. The remaining open question is which specific lot numbers are included, since the recall notice described four lots but the lot identifiers were not provided here.
