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Allergy Medication Recalled Due to Contamination
The affected generic cetirizine tablets may cause serious reactions in some people
AARP (fda.gov, Getty Images)
Key takeaways
- Four lots of generic cetirizine tablets were recalled because they may be contaminated with the drug ranitidine.
- The recall began after a pharmacy technician reported tablets with multiple red spots and discoloration.
- People who have a hypersensitivity to ranitidine could face severe allergic reactions, including anaphylaxis.
Unique Pharmaceutical Laboratories is voluntarily recalling four lots of Cetirizine Hydrochloride Tablets because the allergy medication may be cross-contaminated with ranitidine, according to a notice posted by the Food and Drug Administration.
Cetirizine is an antihistamine used to treat allergy symptoms such as sneezing, runny nose, itchy nose or throat, and red, itchy or watery eyes. It is also used to treat hives. Cetirizine is the active ingredient in Zyrtec, but the FDA recall notice has not included Zyrtec-branded products as part of this recall.
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Why was the allergy medication recalled
A pharmacy technician made the initial complaint after noticing red dots on the cetirizine medication while counting it, with some tablets appearing discolored from multiple red spots.
The company said the affected tablets may be contaminated with ranitidine, an acid-reducing medication used to treat ulcers, gastroesophageal reflux disease (GERD) and conditions in which the stomach produces too much acid. Ranitidine belongs to a class of medications called H2 blockers, which work by decreasing the amount of acid the stomach produces, according to MedlinePlus.
For consumers with a hypersensitivity to ingredients in ranitidine, the company said there is a reasonable probability that taking contaminated cetirizine tablets could cause serious adverse events, including severe hypersensitivity reactions and anaphylaxis. The FDA notice says these reactions may include low blood pressure, difficulty breathing, difficulty swallowing, throat and facial swelling, generalized itching, hives and loss of consciousness, which can be life-threatening.
Unique Pharmaceuticals said it has not received any reports of adverse events related to the recall.
Which allergy medication is recalled?
The recalled tablets were manufactured by Unique Pharmaceutical Laboratories in Panoli, Gujarat, India, and distributed by Rising Pharma Holdings Inc. in HDPE bottles containing 100 tablets.
- Product: Cetirizine Hydrochloride Tablets USP 5 mg
- Package: 100-count HDPE bottle
- NDC: 16571-401-10
- Expiration date: 10/2028
- Distribution: Nationwide to several wholesalers and retailers
Recalled lot numbers:
- GY825029
- GY825030
- GY825031
- GY825032
What should consumers do?
Consumers should check the product name, manufacturer information and lot number printed on the bottle to determine whether their medication is part of the recall.
Rising Pharma Holdings Inc. has notified distributors and direct customers by email and is arranging for the return of all recalled products, according to the FDA notice. However, additional details were not provided.Consumers with general or medical questions about the recall can contact Rising Pharma Holdings Inc. at 844-874-7464 or by email at pv@risingpharma.com or qa@risingpharma.com.
Anyone who believes they experienced a problem related to taking or using the recalled drug should contact their physician or health care provider.
How to report side effects
Adverse reactions or quality problems involving the recalled cetirizine tablets can be reported to the FDA’s MedWatch Adverse Event Reporting program. Consumers can submit a report online or call 800-332-1088 to request a report form. Completed forms can be returned by mail or faxed to 800-FDA-0178.
This article used AI tools to compile recall data. An AARP editor reviewed and refined the content for accuracy and clarity.
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