Rising Pharma Holdings Inc. recalled four lots of 5-milligram cetirizine hydrochloride tablets on July 18 after the allergy medicine was found to may have been cross-contaminated with ranitidine. The tablets were sold in 100-count bottles nationwide through several wholesalers and stores.
The recall lands where consumers would least expect it: in a common medicine used to treat seasonal allergies and hives. Unique Pharmaceutical Laboratories made the tablets in India, while Rising Pharma distributed them. The companies said the problem surfaced when a pharmacy technician was counting tablets and noticed a red dot on some of them, a sign that prompted the recall notice and a posting on the Food and Drug Administration's website.
The size of the recall has not been spelled out in the information released so far, including how many bottles were involved or which exact lot numbers were affected. That leaves buyers with a narrow but important task: check the bottle, not the memory. If the product is among the recalled lots, it should not be used.
The company said Unique Pharmaceutical Laboratories has not received reports of adverse reactions, but it also warned that people with a hypersensitivity to ranitidine could face serious adverse events. Rising Pharma said those customers may suffer anaphylaxis, which could lead to difficulty swallowing or loss of consciousness. That warning is the heart of the recall: a medicine meant for everyday allergy relief may carry a rare but severe risk for a specific group of users.
Ranitidine is normally used to treat heartburn, acid indigestion and sour stomach, not allergies. The contamination concern matters because it turns a routine tablet into a product that could trigger an emergency in the wrong patient. Customers who have the recalled bottles can contact Rising Pharma Holdings Inc. at 1-844-874-7464 between 8 a.m. and 5 p.m. Eastern time Monday through Friday, or report reactions through the MedWatch Adverse Event Reporting program at 1-800-FDA-0178, 1-800-332-1088 or
contacted Rising Pharma on July 21 to ask how many bottles were recalled and did not immediately receive a response. That unanswered number is the last missing piece, but the public-health message is already clear: this is a nationwide allergy medication recall with a contamination risk that should be taken seriously, especially by anyone who knows ranitidine can cause trouble for them.
