Medicines regulation and law
Leading brand of condoms recalled after failing required safety standards
Specific batches of Durex condoms are being recalled after they failed to pass required safety standards. The manufacturer, Reckitt Benckiser Group, has said there is a risk that the condoms might tear or leak, reducing their protection from sexually-transmitted diseases and pregnancy.
The Medicines and Healthcare products Regulatory Agency (MHRA) has advised that people check if they have any of the affected batches. The batch numbers of the faulty products are available on the MHRA website.
“It’s important that you check the batch numbers to see if you have a product from an affected batch. If you have, stop using them as there is a risk that they will tear or leak,” advised John Wilkinson, director of medical devices at the MHRA.
“If you have any questions, please speak to your healthcare professional or sexual health provider.
“Patient safety is our highest priority — we strongly encourage anyone to report any issues with this product, or more generally with any medical device, to our Yellow Card Scheme.”
The MHRA has also issued a Class 3 medicines recall for specific batches of Sodium Cromoglicate 2% w/v Eye Drops 13.5ml and Murine Hayfever Relief 2% w/v Eye Drops 10ml.
The manufacturer, FDC International Ltd., is recalling the product because of the presence of a precipitate, identified as a sodium cromoglicate, in some bottles. Further details are available on the MHRA website.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20205268
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