A pharmaceutical company has voluntarily recalled four lots of its allergy medication, Cetirizine Hydrochloride Tablets USP 5 mg, due to potential cross-contamination with ranitidine, a drug used to treat heartburn and severe acid reflux. The recall was announced by Unique Pharmaceutical Laboratories, a division of J. B. Chemicals & Pharmaceuticals Ltd., on July 18 and posted by the U.S. Food and Drug Administration (FDA) this week.
Immediate Action & Core Facts
The FDA warns that the contamination could be life-threatening for individuals with severe allergies or anaphylaxis to ranitidine. Symptoms of adverse reactions may include hypotension, shortness of breath, difficulty swallowing, throat and facial edema, urticaria, and loss of consciousness. The affected product is packaged in HDPE bottles of 100 tablets (NDC: 16571-401-10) and is set to expire in October 2028.
Deeper Dive & Context
The recall was triggered after a pharmacy technician noticed a red dot on some tablets and other discoloration while counting and bottling the medication. The FDA emphasized that no adverse events related to the recall have been reported to date. Rising Pharma Holdings Inc., the distributor, has notified its customers and is arranging for the return of the recalled drugs. Consumers with questions can contact the company at 1-844-874-7464 or via email at pv@risingpharma.com or qa@risingpharma.com. Patients experiencing issues related to the contaminated drugs are advised to consult their healthcare provider.
The FDA’s recall notice states that for individuals with hypersensitivity to ranitidine, there is a reasonable probability of severe reactions, including anaphylaxis, if they ingest the cross-contaminated cetirizine. The company has not received any reports of adverse events linked to this recall.