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Press release
| Date: | 02 Sep 2004 |
|---|---|
| Time: | 00:00 |
| Subject: | MHRA recalls counterfeit Reductil (reference 2004/0321) |
| Contact: | Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189 |
The Medicines and Healthcare products Regulatory Agency (MHRA) is recalling batch number 65542 of counterfeit Reductil 15 mg Capsules following discovery of counterfeit material in the UK supply chain.
Reductil is used for the treatment of obesity and initial tests by the MHRA of the counterfeit material do not indicate it poses an immediate risk to patients.
Any patient who has product with the batch number 65542 anywhere on the pack, should return it to where it was obtained.
MHRA Chief Executive, Professor Kent Woods said:
"Although the quality of counterfeit medicines cannot be guaranteed, there is no indication from testing of the counterfeit product that it poses an immediate risk to patients. If patients have any concerns about possible side effects they should discuss them with their doctor."
No batches manufactured and distributed by Abbott Laboratories Ltd. are affected by this recall and there is no concern with the Abbott product.
Notes to Editor
1. This is the second such incident of a counterfeit product being discovered in the legitimate UK supply chain since the case involving AZANTAC (ranitidine) tablets in 1994.
2. Reductil is used to treat obesity. The licence holder of the authentic product is Abbott Laboratories Limited.
3. The Medicines and Healthcare products Regulatory Agency (MHRA) investigates all allegations of counterfeit medicines in the UK, the vast majority of which are not associated with the tightly regulated legitimate supply chain. Action in the form of legal proceedings is taken when appropriate.
4. Counterfeit medicines are a global problem, therefore the MHRA continues to liaise closely with international Regulatory partners and the pharmaceutical industry to ensure that the tackling of counterfeiting medicines remains a priority activity.
5. Abbott Laboratories Ltd. are co-ordinating the collection of the counterfeit material on behalf of the MHRA. Enquiries relating to the product should be addressed to: Customer
