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Cetirizine hydrochloride: Why was the allergy medication recalled? Check affected lots, risks and what to do
Rising Pharma Holdings recalled cetirizine hydrochloride tablets. The FDA advises affected consumers to seek medical advice.
A commonly used allergy medication has been recalled in the United States after officials warned that some bottles of cetirizine hydrochloride tablets may have been contaminated with another drug ingredient, potentially causing serious reactions in sensitive individuals.
Rising Pharma Holdings Inc issued a voluntary recall on July 18 for four lots of cetirizine hydrochloride tablets USP 5 mg, which are used to treat seasonal allergies and hives, according to an announcement posted by the US Food and Drug Administration (FDA).
The medication was manufactured by Unique Pharmaceutical Laboratories, a division of JB Chemicals & Pharmaceuticals Ltd, and distributed in the US by Rising Pharma Holdings.
Why was cetirizine hydrochloride recalled?
The recall was initiated after the companies identified possible cross-contamination with ranitidine, a medication previously used to treat heartburn and acid-related conditions.
According to the FDA notice, the issue was discovered after a pharmacy technician noticed a red dot on some tablets while counting medication. The finding prompted further investigation, leading to the recall.
Ranitidine is not intended to be present in cetirizine tablets. The companies warned that people with sensitivity to ranitidine could face serious health risks if they consume the affected medication.
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Which cetirizine tablets are affected?
The recalled products are 100-count bottles of cetirizine hydrochloride tablets. Consumers can identify the affected medication using the details printed on the bottle:
- Manufacturer: Unique Pharmaceutical Laboratories (a division of JB Chemicals & Pharmaceuticals Ltd)
- Distributor: Rising Pharma Holdings Inc
- National Drug Code (NDC): 16571-401-10
- Expiration date: October 2028
- Lot numbers: GY825029, GY825030, GY825031 and GY825032
The recalled medication was distributed nationwide to wholesalers and stores.
What are the possible side effects?
Rising Pharma Holdings said it has not received reports of adverse reactions linked to the recalled tablets. However, the company warned that individuals with hypersensitivity to ranitidine could experience anaphylaxis, a potentially life-threatening allergic reaction.
Possible symptoms include:
- Difficulty swallowing
- Loss of consciousness
- Low blood pressure
- Shortness of breath
- Sudden swelling under the skin
- Throat or facial swelling
- Itching and hives
What should consumers do?
People who have the recalled medication are advised not to use it and should contact their healthcare provider if they experience any health concerns related to taking the drug.
“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 said in its recall notice.
Customers with questions can contact Rising Pharma Holdings between 8 am and 5 pm ET, Monday through Friday, at 1-844-874-7464 or email pv@risingpharma.com or qa@risingpharma.com.
Adverse reactions or quality issues can also be reported through the FDA’s MedWatch Adverse Event Reporting program.
