Key takeaway:
- Rising Pharma has issued cetirizine tablets recalls for four nationwide lots after possible contamination with ranitidine, a mix‑up that poses serious health risks.
- The contamination could trigger severe allergic reactions, including life-threatening anaphylaxis, in sensitive patients.
- Consumers should check affected lot numbers, stop using recalled tablets, and contact their health care provider if symptoms occur.
Rising Pharma Holdings Inc. has announced cetirizine tablets recalls affecting four lots distributed nationwide, after possible contamination with ranitidine. The mix-up raises concerns as it could trigger life‑threatening allergic reactions in sensitive patients.
FDA announces recall after possible cross-contamination
Rising Pharma Holdings Inc., based in New Jersey, issued the voluntary recall on July 18 for four lots of 5-milligram cetirizine hydrochloride tablets used to treat seasonal allergies and hives.
According to a recall notice posted by the U.S. Food and Drug Administration, the tablets may have been cross-contaminated with ranitidine, a medication used to treat heartburn, acid indigestion and sour stomach. The affected tablets were manufactured by Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd. in India, and distributed by Rising Pharma Holdings Inc.
The issue came to light after a pharmacy technician noticed a red dot on some tablets while counting medication, prompting an investigation that led to the recall.
The recalled product was sold nationwide in 100-count bottles bearing National Drug Code 16571-401-10, expiration date October 2028, and lot numbers GY825029, GY825030, GY825031 and GY825032.
Company warns of serious allergic reactions
Rising Pharma said patients with hypersensitivity to ranitidine may face serious adverse events, including anaphylaxis, if they take the contaminated tablets.
Potential symptoms include difficulty swallowing, throat or facial swelling, shortness of breath, low blood pressure, itching, hives and loss of consciousness.
“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 said in its recall announcement.
Unique Pharmaceutical Laboratories said it has not received any reports of adverse reactions linked to the recalled lots.
Contacted Rising Pharma on July 21 seeking information about how many bottles were affected but did not immediately receive a response.
Consumers urged to check lot numbers
Consumers are urged to review their bottles in light of the cetirizine tablets recalls and check whether they match the affected lot numbers before continuing to use the medication.
Rising Pharma said it notified distributors and customers by email after receiving notice of the recall from Unique Pharmaceutical Laboratories.
Customers with questions or medical concerns may contact Rising Pharma Holdings Inc. by phone at 1-844-874-7464 between 8 a.m. and 5 p.m. Eastern time, Monday through Friday, or by emailing pv@risingpharma.com or qa@risingpharma.com.
The FDA also encourages consumers and health care professionals to report adverse reactions or product quality issues through the agency’s MedWatch Adverse Event Reporting Program.
The recall remains ongoing as the companies work with distributors and regulators to remove the affected products from the market.
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