Medicine recalls
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| The United Kingdom: Press release: Medicines watchdog initiates recall of medicines manufactured by Wockhardt Ltd at the Chikalthana site |
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The Medicines and Healthcare products Regulatory Agency (MHRA) asked pharmacies, dispensing clinics and wholesalers to return five different prescription-only medicines in a variety of strengths, which include all unexpired stock of Amiloride HCl 5mg Tablets, Clarithromycin 250mg Tablets, Clarithromycin 500mg Tablets, Gliclazide 80mg Tablets, Quinine Sulphate 300mg Tablets and Tamsulosin Pinexel 400mcg Capsules, for all batches starting with the letter 'L', irrespective of pack configuration and expiry date.
This follows a precautionary recall made by the manufacturer, Wockhardt Ltd, who are asking retail outlets to return five over the counter medicines, which include all unexpired stock of Aspirin 300mg Tablets (Wockhardt & Co-op livery), Extra Pain Control Caplets (Co-op livery), Ibuprofen 200mg Caplets (Superdrug livery), Max Strength Cold & Flu Relief (Superdrug livery) and Paracetamol Extra Strength Tablets (Best In, Galpharm, Happy Shopper & Spar livery), for all batches starting with the letter 'L', irrespective of pack configuration and expiry date.
This action follows manufacturing deficiencies identified by the MHRA during an inspection of Wockhardt’s manufacturing site in Chikalthana, India. The affected medicines are in most cases available from alternative manufacturers and the Department of Health will closely work with them to help ensure that patients can get their medicines when they need them.
Ten prescription-only medicines can continue to be made at the Chikalthana site and can still be supplied to patients in the UK. This is because, due to concerns over the continuity of supply, the benefits to patients of continuing to take these medicines outweigh the risk from any quality concerns with the medicine.
People do not need to return their medicines because there is no evidence that the medicines affected by the precautionary recall in the UK are defective. Therefore, it’s important that people continue to take their medicines as prescribed.
This is not a patient level recall because although the medicines that are affected have not been manufactured to Good Manufacturing Practice (GMP) standards, there is no evidence of a patient safety risk from medicines that have been sold in the UK. However, the MHRA has to act in the interests of public health as poor manufacturing standards means that the quality of medicines is not guaranteed.
The manufacturing deficiencies identified by the MHRA during the inspection of Wockhardt’s Chikalthana site in July 2013 included, poor record keeping relating to the manufacture and testing of the medicines made at the site, and inadequate validation and production controls for medicines. The MHRA is working with Wockhardt and other international regulators to resolve this.
Please refer to the following website in MHRA for details:
http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON326449
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/../CON326448
In Hong Kong, the above products in the announcement are not registered pharmaceutical products.
Ends/ Friday, October 18, 2013
Issued at HKT 16:30 |
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