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Pharmaceutical companies are recalling antihistamine drugs that may be contaminated and cause potentially life-threatening side effects in people taking the drugs.
New Jersey-based pharmaceutical company Rising Pharma Holdings announced on July 18 a recall of four lots of 5-milligram cetirizine hydrochloride tablets, which are used to treat seasonal allergies and hives.
The drug was manufactured by Unique Pharmaceutical Laboratories, an India-based company, and distributed by Rising Pharma Holdings, according to an announcement on the Food and Drug Administration’s website.
The companies said the cetirizine hydrochloride tablets may have been cross-contaminated with ranitidine, which is used to treat heartburn, indigestion and sour stomach. The drug reduces the amount of acid produced in the stomach, according to Medline Plus and the U.S. National Library of Medicine.
According to an announcement on the FDA’s website, the companies discovered that the pills may have been at fault after a pharmacy technician counted the pills and noticed red dots on some of the pills.
Here’s what else we know about the recall.
What exact drugs are being recalled?
The recalled cetirizine hydrochloride tablets are sold in 100-count bottles. Customers can identify recalled products by looking at the product name, manufacturer details and lot number displayed on the bottle.
Identification information includes:
- Manufacturer – Unique Pharmaceutical Laboratories (a division of JB Chemicals & Pharmaceuticals Ltd)
- Distributor – Rising Pharma Holdings Co., Ltd.
- National drug code number – 16571-401-10
- Expiry date – October 2028
- Lot number – GY825029, GY825030, GY825031, GY825032
Unique Pharmaceuticals notified Rising Pharma Holdings Inc. of the recall, and Rising Pharma Holdings Inc. notified its distributors and customers via email.
How many drugs have been recalled?
USA TODAY reached out to Rising Pharma Holdings on July 21 to ask about the number of recalls, but did not immediately receive a response.
Where was the recalled drug sold?
The product was sold to several wholesalers and stores across the country.
Side effects may include difficulty swallowing
Although Unique Pharmaceutical Laboratories has not received any reports of adverse reactions to cetirizine hydrochloride tablets, customers with sensitivities to ranitidine ingredients may experience “serious adverse events,” the statement said.
Rising Pharma Holdings said customers with hypersensitivity to ranitidine who take contaminated cetirizine hydrochloride tablets may experience anaphylaxis.
In addition to difficulty swallowing and loss of consciousness, anaphylaxis can cause symptoms such as:
What should I do if I have a recalled drug?
Customers with questions or medical concerns may contact Rising Pharma Holdings Inc. at 1-844-874-7464, Monday through Friday, 8 a.m. to 5 p.m. Eastern Time. You can also send an email to pv@risingpharma.com or qa@risingpharma.com.
“Consumers should contact their physician or health care provider if they experience any problems that may be related to taking or using this medication,” Rising Pharma Holdings wrote.
The company said customers can report side effects or quality issues to the FDA’s MedWatch Adverse Event Reporting Program by completing and submitting a report at www.fda.gov.
Customers may also request a reporting form by downloading the form from www.fda.gov/MedWatch/getforms.htm or by calling 1-800-332-1088, completing the pre-addressed form and returning it by mail or fax to 1-800-FDA-0178.
Saleen Martin is a reporter on USA TODAY’s Trends team. She is from Norfolk, Virginia (757). Email sdmartin@usatoday.com.
