TOPIC: Cetirizine Hydrochloride Tablets USP 5 mg by Unique Pharmaceutical Laboratories: Recall - Due to Potential Cross Contamination with Ranitidine
AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy
ISSUE: Unique Pharmaceutical Laboratories is recalling four lots of Cetirizine Hydrochloride Tablets USP 5 mg due to cross contamination with Ranitidine.
Risk Statement: For consumers with a hypersensitivity to the ingredients in ranitidine, there is a reasonable probability that ingestion of Cetirizine tablets contaminated with ranitidine could result in serious adverse events including severe hypersensitivity reactions and anaphylaxis that manifests as hypotension, dyspnea, difficulty swallowing, throat and facial edema, generalized pruritic, urticaria, and loss of consciousness, which are all life-threatening.
To date, Unique Pharmaceuticals has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The product being recalled is used as an antihistamine.
RECOMMENDATIONS:
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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.
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Consumers with general or medical inquiries regarding this recall can contact Rising Pharma Holdings Inc. at: Phone number: 1-844-874-7464 or e-mail: pv@risingpharma.com or qa@risingpharma.com.
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