Voluntary nationwide recall: Cetirizine (Unique – July)

Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) is recalling four lots (GY825029, GY825030, GY825031, GY825032) of Cetirizine Hydrochloride Tablets USP 5 mg. Cetirizine is used for the relief of allergy symptoms, including itchy, red, watery eyes and itchy skin.

This drug is being recalled because the affected lots were cross contaminated with Ranitidine. The cross contaminated Cetirizine tablets were found to have red dots on the tablets. Ranitidine is used for the treatment of heartburn. Taking Cetirizine that has been cross contaminated with Ranitidine could result in severe reactions including shortness of breath and difficulty swallowing in people who are allergic to the ingredients in Ranitidine.

To see if your medication was recalled, contact your doctor or pharmacy where you received it or visit the FDA website below. If you have an affected lot of Cetirizine or are experiencing any problems that may be related to receiving the product, you should stop using it and talk to your doctor.

As of July 20, there had been no reports of adverse events related to this recall.

To learn more about this recall, you can take one or more of the steps below.

• Talk to your doctor or pharmacist.
• Call Rising Pharma Holdings Inc. at 844-874-7464. TTY users should call 711. Help is available Monday through Friday from 8 a.m. to 5 p.m. EST.
• Visit the FDA website.