Unique Pharmaceutical Laboratories has issued a voluntary recall for four specific lots of Cetirizine Hydrochloride Tablets USP 5 mg due to potential cross-contamination with ranitidine. The recall, initiated July 18 and published by the U.S. Food and Drug Administration (FDA) on July 20, follows the discovery of discolored tablets containing red dots by a pharmacy technician. While no adverse events have been reported, the contamination poses a risk of severe hypersensitivity reactions, including anaphylaxis, for consumers sensitive to ranitidine.
Identification of Recalled Cetirizine Lots
The recall affects 100-count HDPE bottles of Cetirizine Hydrochloride Tablets, distributed nationwide by Rising Pharma Holdings Inc. The affected products bear the National Drug Code (NDC) 16571-401-10. Consumers are urged to inspect their medication labels for the following lot numbers and expiration dates:
- Lot GY825029: Expiration October 2028
- Lot GY825030: Expiration October 2028
- Lot GY825031: Expiration October 2028
- Lot GY825032: Expiration October 2028
Pro Tip: Always check the physical appearance of your medication. In this instance, the contamination was first identified by a pharmacy technician who noticed unusual red dots and discoloration on the tablets.
Health Risks Associated with Ranitidine Cross-Contamination
Ranitidine, formerly marketed as Zantac, is a histamine-2 blocker used to treat stomach acid conditions. While accidental exposure is generally not harmful to the average user, the FDA notes that individuals with specific sensitivities may experience severe reactions. According to the recall announcement, these can include life-threatening anaphylaxis, characterized by difficulty breathing, throat swelling, a sudden drop in blood pressure, and loss of consciousness.
Steps for Consumers and Reporting Procedures
Unique Pharmaceutical Laboratories is coordinating with Rising Pharma Holdings Inc. to facilitate the return of the affected stock. Consumers who possess these specific lots should stop using the medication immediately and consult their healthcare provider if they have concerns about potential exposure.
For inquiries regarding the return process, Rising Pharma Holdings Inc. can be reached at 1-844-874-7464, Monday through Friday, between 8 a.m. and 5 p.m. EST. Questions may also be directed to the company via email at [email protected] or [email protected].
Did you know? You can report adverse reactions or quality concerns directly to the FDA’s MedWatch program. Reports can be filed online at www.fda.gov/medwatch/report.htm, by calling 1-800-332-1088, or via fax at 1-800-FDA-0178.
Frequently Asked Questions
What should I do if I have already taken the recalled tablets?
Contact your physician or healthcare provider promptly if you have experienced any adverse reactions or symptoms related to the medication.
Is the entire supply of Cetirizine being recalled?
No. The recall is limited to four specific lots (GY825029, GY825030, GY825031, and GY825032) distributed by Rising Pharma Holdings Inc.
Why did the contamination happen?
The recall was initiated following the discovery of cross-contamination. While the exact mechanism of the transfer remains under investigation, the presence of red dots on the tablets served as the primary indicator of the issue.
Have you checked your medicine cabinet for these lot numbers? Share this alert with family members who may use over-the-counter antihistamines. For more updates on pharmaceutical safety, subscribe to our health newsletter.