Broadcast Content: Medicines and Healthcare Products Regulatory Agency Defective Medicines Report Centre Market Towers 1 Nine Elms Lane London SW8 5NQ Telephone: 020 7084 2574 Facsimile: 020 7084 2676
Action Within 48 Hours PATIENT LEVEL RECALL (see below) Date: 02 September 2004 EL(04)A/08 Our Ref: MDR 01-07/04
Counterfeit Product Batch Number: 65542 Expiry Date: 01/2007 Pack Size: Blisters of 28 capsules supplied in 2 strips of 14 First Distributed: Not known
The MHRA, with assistance offered by Abbott Laboratories Ltd., is recalling the above batch of counterfeit Reductil 15 mg Capsules only. No batches manufactured and distributed by Abbott Laboratories Ltd. are affected by this recall. This follows discovery of counterfeit material in the UK supply chain. The initial results of the analysis performed by the MHRA on the counterfeit material do not indicate that this material poses an immediate risk to patients.
The packs are a very close match in appearance to the authentic product but may be distinguished by the batch number. The counterfeit product batch number is purely numeric (eg. 65542). Authentic material produced by Abbott Laboratories Ltd. in the UK possesses a numeric batch number with a one letter alphabetic suffix (eg. 141998D). It is not known if batch numbers other than that quoted above are involved.
Please check stock and inform the MHRA immediately if other material with purely numeric batch numbers is identified.
To return counterfeit product you should contact Abbott Laboratories Ltd., who are co-ordinating the recovery of the counterfeit material on behalf of the MHRA, care of:
Where patients are known to (or may) have been provided with counterfeit product they should be contacted by the dispensing professional and counterfeit material retrieved for return to Abbott Laboratories Ltd.
Primary Care Trusts are asked to bring this information to the attention of Community Pharmacists and General Practitioners by copy of this letter.
In case of queries, please contact Abbott Laboratories, UK on the number above.
PLEASE RECALL TO PATIENT LEVEL
Yours faithfully,
Graham Matthews Pharmaceutical Assessor DMRC QUESTIONS AND ANSWERS FOR PATIENTS Why is this batch of product being recalled? Product with this batch number is counterfeit (fake) material that is not legally available in the UK. Where can the batch number be found on the pack? The batch number is printed on the end of the box and is next to the expiry date. It is also printed on the foil backing of the blister strip containing the capsules. What should I do if I have counterfeit product with this batch number? Do not take any more. Return the product to where you obtained it (e.g. a pharmacy), obtain a replacement of genuine Abbott Reductil as prescribed by your doctor and continue to take your replacement medication as prescribed by your doctor. If you are concerned, consult your healthcare professional (doctor/pharmacist). What happens if I have taken tablets from this batch? Initial tests performed by the MHRA on this counterfeit material do not indicate that it poses an immediate risk to patients. Do not take any more. Return the product to where you obtained it (e.g. pharmacy), obtain a replacement of genuine Abbott Reductil as prescribed by your doctor and continue to take your replacement medication as prescribed by your doctor. If you are concerned, consult your healthcare professional (doctor/pharmacist). If the product does not have any safety problems, why is it being recalled? There are two reasons: