Rising Pharma Holdings Inc. recalled four lots of 5-milligram cetirizine hydrochloride tablets packaged in 100-count bottles due to cross-contamination with ranitidine, according to a voluntary recall notice announced on July 18. The nationwide recall affects common seasonal allergy and hive medication manufactured by Unique Pharmaceutical Laboratories in India, with the contamination discovered after a pharmacy technician spotted a red dot on the tablets.
Recall Details and Affected Medication Lots
The recalled cetirizine hydrochloride tablets carry National Drug Code No. 16571-401-10, an expiration date of 10/2028, and specific lot numbers GY825029, GY825030, GY825031, and GY825032, according to the recall notice. Unique Pharmaceutical Laboratories manufactured the antihistamine, which New Jersey-based Rising Pharma Holdings Inc. distributed across the United States. According to the company, the issue came to light when a pharmacy technician noticed an unusual red dot while counting the pills. Consumers can verify their medicine by checking the bottle label for these specific manufacturer details, NDC numbers, and lot identifiers before taking any more doses.
Health Risks and Ranitidine Cross-Contamination
Cross-contamination with ranitidine—a medication typically used for heartburn, acid indigestion, and sour stomach—poses severe health risks for certain patients, according to Rising Pharma. While Unique Pharmaceutical Laboratories reported no adverse reactions at the time of the announcement, the recall warning states that individuals with a hypersensitivity to ranitidine could experience serious adverse events. According to the voluntary recall, contaminated tablets have the potential to trigger anaphylaxis in sensitive people. This severe allergic reaction can become life-threatening, bringing symptoms such as difficulty swallowing and a complete loss of consciousness.
Consumer Action and Reporting Guidelines
Anyone possessing the affected antihistamine should immediately check their bottle label for the designated manufacturer information, NDC number, expiration date, and four recalled lot numbers, per the recall notice. For direct inquiries or medical concerns, Rising Pharma Holdings Inc. is available Monday through Friday from 8 a.m. to 5 p.m. Eastern at 1-844-874-7464, or via email at [email protected] and [email protected]. Patients who believe the medication has caused a reaction must contact a doctor immediately. Additionally, consumers can report side effects or product quality issues through the FDA’s MedWatch Adverse Event Reporting program online, by mail, or by fax, while Rising Pharma works to retrieve all contaminated products.
Did You Know?
In this case, a routine pill count caught the contamination when a technician spotted an unexpected red dot on the tablets.
Frequently Asked Questions
What specific product is being recalled?
Rising Pharma Holdings Inc. recalled four lots of 5-milligram cetirizine hydrochloride tablets packaged in 100-count bottles, manufactured by Unique Pharmaceutical Laboratories.
How do I know if my allergy medicine is affected?
Check your bottle for National Drug Code No. 16571-401-10, an expiration date of 10/2028, and lot numbers GY825029, GY825030, GY825031, or GY825032.
What are the primary health risks?
According to the recall notice, cross-contamination with ranitidine can trigger anaphylaxis in people with a hypersensitivity to ranitidine, causing life-threatening symptoms like difficulty swallowing and loss of consciousness.
Who should I contact if I have questions or experienced a reaction?
Contact Rising Pharma at 1-844-874-7464 or email [email protected] or [email protected]. Contact a doctor immediately if you experience a reaction, and report issues through the FDA MedWatch program.
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