Rising Pharma Holdings Inc. issued a Cetirizine recall on July 18 for four lots of 5-milligram cetirizine hydrochloride tablets after the product may have been cross-contaminated with ranitidine. The tablets are sold in 100-count bottles and were distributed nationwide to several wholesalers and stores.
The recall centers on tablets used to treat seasonal allergies and hives. Unique Pharmaceutical Laboratories manufactured the medication in India, while Rising Pharma Holdings Inc. distributed it. A pharmacy technician noticed a red dot on some tablets while counting them, which prompted concern about the product.
Rising Pharma Holdings Inc.
Rising Pharma Holdings Inc. said customers with a sensitivity to ranitidine and contaminated cetirizine hydrochloride tablets may suffer anaphylaxis. The company said that could lead to difficulty swallowing or loss of consciousness. It also said 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.
Unique Pharmaceutical Laboratories
Unique Pharmaceutical Laboratories had not received reports of adverse reactions to the cetirizine hydrochloride tablets. Even so, the recall covers four lots, so customers checking a bottle need the lot number on the label, the 5-milligram strength, and the 100-count bottle size to see whether the product matches the recalled batch.
FDA MedWatch Adverse Event Reporting program
Consumers who think they took the recalled tablets can contact Rising Pharma Holdings Inc. at 1-844-874-7464 from 8 a.m. to 5 p.m. Eastern time Monday through Friday. They can also report adverse reactions through the FDA MedWatch Adverse Event Reporting program at by phone at 1-800-332-1088, or by fax at 1-800-FDA-0178.
The immediate question for customers is whether a bottle in the medicine cabinet matches one of the four lots, because the recall covers a nationwide product sold in 100-count bottles and the warning includes people with hypersensitivity to ranitidine ingredients.
