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1 abcdefghijklm eé~äíüaéé~êíãéåí pí^åçêéïûëeçìëé oéöéåíoç~ç bçáåäìêöübenpad IMMEDIATE MESSAGE TO: qéäééüçåéwmnpnjoqqjorou c~ñwmnpnjoqqoptr ÉJã~áäWáêÉåÉKÑçëíÉê]ëÅçíä~åÇKÖëáKÖçîKìâ 1. Specialists in Pharmaceutical Public Health 2. Chief Pharmacists, NHS Boards 3. Hospital Pharmacy Managers 4. Medical Directors NHS Boards lìêêéñw mitlplt a~íéwosgìåéommt Dear Healthcare Professional, DRUG ALERT NO : CLASS 2 Please find attached class 2 drug alert from the Medicines and Healthcare Products Regulatory Agency (MHRA) for onward transmission (see list below). 1. Please could Specialists in Pharmaceutical Public Health/Directors of Pharmacy forward this alert to:- Community Pharmacists Chief Pharmacists to forward on to Medicines Information Pharmacists 2. Please could Medical Directors forward the message on to:- General Practitioners Dispensing Doctors Chief Executives, NHS Boards Thank you for your co-operation. Yours sincerely IRENE FOSTER Pharmacy Division * NB: Drug alerts have the following classifications: 1. Action now (including out-of-hours); 2. Action within 48 hours; 3. Action within 5 days; 4. Caution in use

2 Class 2 Drug Alert (action within 48 hours): Chatfield brand Amoxicillin suspensions and Dedoxil brand Amoxicillin capsules DRUG ALERT CLASS 2 MEDICINES RECALL Action within 48 Hours PHARMACY (or equivalent) LEVEL RECALL 26 June 2007 EL(07)A/11 Our ref: MDR 38-06/07 Document details: Type: Drug Alert Series No: EL(07)A/11 Audience: Healthcare professional Published: Format: Electronic and paper Size: A4 Pages: 2 Price: free ISBN/ISSN: Author: Copyright: Crown Product: Chatfield Brand Amoxicillin Suspensions Amoxicillin Suspensions 125 mg / 5 ml Amoxicillin Suspensions 250 mg / 5 ml All batches expiring in August 2007 Chatfield Pharmaceuticals Ltd PL 02142/0010 PL 02142/0011 Product: Dedoxil Brand Amoxicillin Capsules Amoxicillin Capsules 250 mg x 21 and 250 mg x 500 Amoxicillin Capsules 500 mg x 21 and 500 mg x 100 All batches expiring on or before May 2009 DDSA Pharmaceuticals Ltd PL 0225/0071 PL 0225/0072 Chatfield and DDSA Pharmaceuticals Ltd are recalling the above products due to concerns with the quality of the active ingredient used in their manufacture.

3 Recipients are requested to quarantine any remaining stock and return it to their supplier for credit. For further information and other enquiries please contact Recipients of this Drug Alert should bring this information to the attention of relevant contacts by copy of this letter. Primary Care Trusts are asked to bring this information to the attention of General Practitioners and Community Pharmacists by copy of this letter. Yours faithfully, Ian Holloway DMRC Manager 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) Medical Supplies Agency (MOD) Chief Pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar Special Hospitals Healthcare Commission for distribution to Independent Health Care Establishments

4 abcdefghijklm eé~äíüaéé~êíãéåí pí^åçêéïûëeçìëé oéöéåíoç~ç bçáåäìêöübenpad IMMEDIATE MESSAGE TO: qéäééüçåéwmnpnjoqqjomqm c~ñwmnpnjoqqoptr ÉJã~áäWäÉëäáÉKëãáíÜ]ëÅçíä~åÇKÖëáKÖçîKìâ 1. Specialists in Pharmaceutical Public Health 2. Chief Pharmacists, NHS Boards 3. Hospital Pharmacy Managers 4. Medical Directors NHS Boards lìêêéñw mitlplt a~íéwotgìåéommt Dear Healthcare Professional, DRUG ALERT NO : CLASS 2 further information Please find attached class 2 drug alert from the Medicines and Healthcare Products Regulatory Agency (MHRA) for onward transmission (see list below). 1. Please could Specialists in Pharmaceutical Public Health/Directors of Pharmacy forward this alert to:- Community Pharmacists Chief Pharmacists to forward on to Medicines Information Pharmacists 2. Please could Medical Directors forward the message on to:- General Practitioners Dispensing Doctors Chief Executives, NHS Boards Thank you for your co-operation. Yours sincerely LESLIE SMITH Pharmacy Division * NB: Drug alerts have the following classifications: 1. Action now (including out-of-hours); 2. Action within 48 hours; 3. Action within 5 days; 4. Caution in Use.

5 Class 2 Drug Alert (action within 48 hours): Chatfield brand amoxicillin suspensions and Dedoxil brand amoxicillin capsules DRUG ALERT CLASS 2 MEDICINES RECALL Action within 48 Hours PHARMACY (or equivalent) LEVEL RECALL 26 June 2007 EL(07)A/11 Our ref: MDR 38-06/07 Document details: Type: Drug Alert Series No: EL(07)A/11 Audience: Healthcare professional Published: Format: Electronic and paper Size: A4 Pages: 2 Price: free ISBN/ISSN: Author: Copyright: Crown Product: Chatfield Brand Amoxicillin Suspensions Amoxicillin Suspensions 125 mg / 5 ml Amoxicillin Suspensions 250 mg / 5 ml All batches expiring in August 2007 Chatfield Pharmaceuticals Ltd PL 02142/0010 PL 02142/0011 Product: Dedoxil Brand Amoxicillin Capsules Amoxicillin Capsules 250 mg x 21 and 250 mg x 500 Amoxicillin Capsules 500 mg x 21 and 500 mg x 100 All batches expiring on or before May 2009 DDSA Pharmaceuticals Ltd PL 0225/0071 PL 0225/0072 Chatfield and DDSA Pharmaceuticals Ltd are recalling the above products due to concerns with the quality of the active ingredient used in their manufacture. Please note that further to the earlier Drug Alert relating to the above products that these batches may be in Genesis Pharmaceuticals livery. Additionally, the Dedoxil brand identity is only visible on the capsules of the inner packs. Recipients are requested to quarantine any remaining stock and return it to their supplier for credit. For further information and other enquiries please contact Recipients of this Further Information Document should bring this information to the attention of relevant contacts by copy of this letter. Primary Care Trusts are asked to bring this information to the attention of General Practitioners and Community Pharmacists by copy of this letter. Yours faithfully, Graham Matthews Senior Pharmaceutical Assessor