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A pharmaceutical company has recalled an antihistamine that may have been contaminated, potentially leading to life-threatening side effects for those who take the medication.
New Jersey-based pharmaceutical company Rising Pharma Holdings Inc. issued a recall on July 18 for four lots of 5-milligram cetirizine hydrochloride tablets, which are used to treat seasonal allergies and hives.
A company based in India, Unique Pharmaceutical Laboratories, manufactured the medication, which Rising Pharma Holdings Inc. then distributed, according to an announcement on the Food and Drug Administration’s website.
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According to the companies, the cetirizine hydrochloride tablets may have been cross-contaminated with ranitidine, which is used to treat heartburn, acid indigestion and sour stomach. The medication decreases the amount of acid made in the stomach, according to MedlinePlus and the U.S. National Library of Medicine.
The companies found out there may have been an issue with the tablets when a pharmacy technician was counting tablets and saw a red dot on some of them, according to the announcement on the FDA’s website.
Here’s what else we know about the recall:
What is the exact medication being recalled?
The recalled cetirizine hydrochloride tablets are sold in 100-count bottles. Customers can identify the recalled product by looking at its name, manufacturer details and lot number displayed on the bottle.
Identifying information includes:
- Manufacturer – Unique Pharmaceutical Laboratories (a division of J.B. Chemicals & Pharmaceuticals Ltd.)
- Distributor – Rising Pharma Holdings Inc.
- National Drug Code No. – 16571-401-10
- Expiration date – 10/2028
- Lot numbers – GY825029, GY825030, GY825031, GY825032
Unique Pharmaceuticals let Rising Pharma Holdings Inc. know about the recall, and Rising Pharma Holdings Inc. then let distributors and customers know via email.
How many bottles of the medication are being recalled?
USA TODAY contacted Rising Pharma Holdings Inc. on July 21 to find out how many bottles were recalled but did not immediately receive a response.
Where was the recalled medication sold?
The product was sold nationwide to several wholesalers and stores.
Adverse reactions may include difficulty swallowing
While Unique Pharmaceutical Laboratories has not received reports of adverse reactions to the cetirizine hydrochloride tablets, customers with a hypersensitivity to the ingredients in ranitidine could experience “serious adverse events,” the announcement said.
Rising Pharma Holdings Inc. said customers who have a sensitivity to ranitidine and take the contaminated cetirizine hydrochloride tablets may suffer anaphylaxis.
Anaphylaxis could lead to difficulty swallowing or loss of consciousness, as well as symptoms such as:
- Hypotension or low blood pressure
- Dyspnea or shortness of breath
- Angioedema or sudden swelling under the skin
- Throat and facial swelling
- Pruritus or itchiness
- Uticaria or hives
What to do if you have the recalled medication
Customers with questions or medical concerns can contact Rising Pharma Holdings Inc. between 8 a.m. and 5 p.m. Eastern time Monday through Friday at 1-844-874-7464. They can also email [email protected] or [email protected].
“Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product,” Rising Pharma Holdings Inc. wrote.
The company said customers can report adverse reactions or quality problems to the FDA's MedWatch Adverse Event Reporting program by completing and submitting a report at www.fda.gov.
Customers can also download the form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return the pre-addressed paperwork via mail or by fax to 1-800-FDA-0178.
Saleen Martin is a reporter on USA TODAY’s trending team. She is from Norfolk, Virginia – the 757. Email her at [email protected].
This article originally appeared on USA TODAY: Bottles of antihistamine tablets recalled. See the affected products
