The UK’s MHRA has issued a recall warning for unexpired Zantac products manufactured by GlaxoSmithKline (GSK) due to possible contamination of the drug with ranitidine.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has announced that GlaxoSmithKline (GSK) is recalling all unexpired UK stocks of four Zantac products used to treat heartburn and stomach ulcers.
The MHRA has issued a warning to healthcare professionals about the recall of these prescription medicines.
According to the MHRA, the recall is a precautionary measure as ranitidine may be contaminated with the impurity N-nitrosodimethylamine (NDMA). NDMA is a possible human carcinogen.
The four products affected are Zantac 150 mg/10 ml syrup, Zantac 50 mg/2 ml injection tablets, Zantac 150 mg tablets and Zantac 300 mg tablets.
Health workers were ordered to immediately stop supplying drugs, quarantine any remaining supplies and return them to suppliers. The MHRA also requires manufacturers to separate any ranitidine products that may contain an active pharmaceutical ingredient (API).
Dr Andrew Gray, Deputy Director of Inspection, Enforcement and Standards at the MHRA, commented: “We have asked the company to isolate potentially affected batches of medicines during our investigation and will take appropriate action, including recalling the product where necessary.
“We are also asking the relevant companies to carry out a risk assessment, which will include testing of potentially affected batches.”
The over-the-counter products Zantac 75 Relief (PL 02855/0081 [GSL]) and Zantac 75 Tablets (PL 02855/0082 [P]) are manufactured by different companies and are not subject to recall.
Издатель European Drug Review: Russell Publishing Ltd. Court Lodge Hogtro Hill Brasted, Kent, TN16 1NUUnited Kingdom
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Post time: Dec-05-2023