Class 2 Drug Alert (Action within 48 hours): Acino Pharma GmbH - Clopidogrel 75 mg Tablets - EL (10)A/09

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Dear Healthcare Professional,

EU/1/09/554/003 (Ratiopharm UK livery)

EU/1/09/547/003 (Sandoz UK livery)

Statement Acino Pharma GmbH is carrying out a precautionary medicine recall of several batches of Clopidogrel 75mg tablets at wholesale and pharmacy level. In the UK the product has been distributed in both Ratiopharm UK and Sandoz UK packaging. Clopidogrel is an antiplatelet medicine that is used to prevent problems associated with blood clots such as heart attacks or strokes. This follows concerns about Good Manufacturing Practices (GMP) for the active pharmaceutical ingredient used in the product. This product is made at a manufacturing site in India. As a precautionary measure, the European Medicines Agency last week recommended that all batches containing Clopidogrel active ingredient, manufactured at the Glochem Visakhapatnam factory in India, be recalled from the entire supply chain after inspections found that the site was not GMP compliant. In the UK, only Sandoz and Ratiopharm liveries of the product are affected. There is no specific evidence to suggest that the medicines are not safe for patient use. People who have these medicines do not need to worry and should continue to take their medication. If patients have any concerns, they should speak to their doctor or pharmacist. The MHRA has issued a Class 2 Drug Alert to healthcare professionals to support this precautionary recall. The recall only relates to the medicines and batch numbers that are specified in the published drug alert.

Acino Pharma GmbH is recalling several batches of the Clopidogrel 75 mg tablets due to concerns about Good Manufacturing Practices at the production site for the active pharmaceutical ingredient. A list of affected batches is attached as Appendix 1.

Stock from the marketing authorisation holder Acino Pharma GmbH has been distributed in Ratiopharm UK livery and Sandoz UK livery. Two different marketing authorisation numbers are used and are quoted above.

For Ratiopharm UK Ltd medical information enquiries please contact 012392 313589.

For Sandoz UK Ltd medical information enquiries please call 01276 698020.

Remaining stocks of the above batches should be returned to the original wholesaler for credit. For further stock enquiries please contact Ratiopharm UK Ltd on 02392 313585 or Sandoz Customer Services on 01276 698020.

Recipients of this Drug Alert are requested to bring it to the attention of relevant professionals by copy of this letter. Primary Care Trusts are asked to forward this document to hospitals and relevant clinics.

Yours faithfully

Ian Holloway
DMRC Manager

 

Appendix 1

Ratiopharm UK livery

Pack size	Batch number	Expiry date	First distributed
30 tablets	J25220	30/06/2012	14/10/2009
30 tablets	J25241	30/07/2012	6/11/2009

Sandoz UK Livery

Pack size	Batch number	Expiry date	First distributed
30 tablets	9A0342	8/2012	26/11/2009
30 tablets	9A0343	8/2012	13/10/2009
30 tablets	9A0344	8/2012	15/10/2009
30 tablets	9A0345	8/2012	30/10/2009
30 tablets	9A0349	8/2012	20/01/2010
30 tablets	9A0350	8/2012	11/02/2010
30 tablets	9A0351	8/2012	13/10/2009
30 tablets	9D0355	10/2012	17/03/2010
30 tablets	9D0356	10/2012	23/03/2010
30 tablets	9D0357	10/2012	16/03/2010
30 tablets	9Y0326	10/2012	18/03/2010
30 tablets	9Y0327	10/2012	11/03/2010

 

MHRA Distribution (further recipients by cascade):

Regional contacts for NHS trusts and provider units
Chief pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special hospitals
Healthcare Commission for distribution to independent health care establishments
Primary care trusts (England)