SerpApi.Org
An allergy medication found in cabinets across the country may contain something that was never supposed to be in the bottle.
Unique Pharmaceutical Laboratories is voluntarily recalling four lots of cetirizine hydrochloride 5 mg tablets because of potential cross-contamination with ranitidine, an acid-reducing medication used to treat heartburn and other conditions.
The company announced the nationwide recall in a notice posted by the Food and Drug Administration this week.
The FDA posts company recall announcements as a public service and does not endorse the product or company. The recall is being conducted with the agency’s knowledge.
People who are hypersensitive to ingredients in ranitidine could suffer a severe or potentially life-threatening reaction after taking contaminated cetirizine tablets, according to the company.
Possible reactions include low blood pressure, difficulty breathing or swallowing, swelling of the throat or face, hives, severe itching, and loss of consciousness.
No adverse events connected to the recall have been reported.
Cetirizine is an antihistamine used to treat allergy symptoms. The recalled tablets were manufactured by Unique Pharmaceutical Laboratories and distributed by Rising Pharma Holdings Inc.
They were sold nationwide through multiple wholesalers and retailers in bottles containing 100 tablets.
All affected bottles carry NDC 16571-401-10 and an expiration date of October 2028. The recalled lot numbers are:
- GY825029
- GY825030
- GY825031
- GY825032
A pharmacy technician discovered the problem while counting tablets for dispensing. A product complaint described red dots and discoloration on some tablets.
Unique Pharmaceutical Laboratories said the affected tablets may have been cross-contaminated with ranitidine.
Consumers can view photographs of the bottle, label, and tablets on the FDA website. The page also displays the product and lot codes.
Rising Pharma has notified distributors and direct customers and is arranging for recalled bottles to be returned.
People with a matching bottle can call Rising Pharma at 1-844-874-7464 from 8 a.m. to 5 p.m. Eastern time, Monday through Friday. Questions can also be emailed to [email protected] or [email protected].
Anyone who experienced a problem that may be connected to the medication should contact a physician or health care provider. Adverse reactions can also be reported through the FDA’s MedWatch program.
Check back with Daily Voice for the latest updates.
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