Medicine recalls
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| The United States: Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) issues voluntary nationwide recall of Cetirizine Hydrochloride Tablets USP 5 mg due to potential cross contamination with Ranitidine |
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The US Food and Drug Administration (FDA) announces that Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) is voluntarily recalling 4 lots of Cetirizine Hydrochloride Tablets USP 5 mg (lot number: GY825029, GY825030, GY825031, GY825032) to the consumer level due to cross contamination with Ranitidine.
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.
The product is used as an Antihistamine and is packaged in HDPE Bottle pack of 100 tablets.
Product complaint received that a pharmacy technician identifies the discrepancy while counting the tablets at the time of dispensing. A product complaint reported about appearance of red dot on Tablets of Cetirizine Hydrochloride Tablets USP 5 mg and some tablets are discolored (Appeared as discolored due to multiple red colored dots on tablets).
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/unique-pharmaceutical-laboratories-div-j-b-chemicals-pharmaceuticals-ltd-issues-voluntary-nationwide
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Jul 21, 2026
Issued at HKT 17:30
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