Alert by medicines regulator about recall of some Temozolomide chemotherapy capsules
Here is the official MHRA (Medicines and Healthcare products Regulatory Agency) information about the 
Temozolomide recall in the UK.
DETAILS FOR HOSPIRA TEMOZOLOMIDE
Class 1 Drug Alert (Action now – including out of hours): Hospira UK Ltd - Temozolomide Hospira Capsules - EL (10)A/15
DRUG ALERT
CLASS 1 MEDICINES RECALL
Action now – including out of hours
CLASS 1 MEDICINES RECALL 06 July 2010 EL (10)A/15 Our ref: MDR 03-07/10
----------------------------------------------------------
Dear Healthcare Professional,
Hospira UK Ltd
Temozolomide Hospira Capsules
EU/1/10/615/001 TO 024
Batch number Strength Pack size First distributed
L00828 5 mg 5 capsules 15 April 2010
L00829 20 mg 5 capsules 6 April 2010
L00831 100 mg 5 capsules 6 April 2010
L01031 250 mg 5 capsules 6 April 2010
Hospira UK Ltd is recalling the above batches to patient level due to reports of broken capsules and leakage. We understand this product is normally supplied via hospitals and not from general practitioners or community pharmacy.
Pharmacists and clinics are requested to contact patients and ask them to return any stock of the above batches without further opening of the containers. If external contamination of the containers is suspected handle whilst wearing latex or nitrile gloves. Place the container in a polyethylene bag and seal prior to return.
Contact of the capsule contents with skin or mucosa should be avoided. In the event of such contact the area should be immediately and thoroughly washed with soap and water and medical advice sought promptly. In the case of eye contact remove from source of exposure then flush with copious amounts of water. If irritation persists or signs of toxicity occur, seek medical attention.
We understand that alternative product is available from other marketing authorisation holders. Patients should be advised to obtain an alternative prescription and replacement stock as soon as possible.
Pharmacists are asked to quarantine any remaining stock from these batches, package it thoroughly, as described above, and return it to Hospira for credit. For contact with Hospira Customer Services please call 0800 028 7304 0800 028 7304 . If pharmacists have any concerns about possible external contamination, they should call Hospira UK Ltd on 01926 834 400 01926 834 400 to seek advice before returning the stock.
For medical information enquiries, please call Hospira UK Ltd on 01926 834 400 01926 834 400 Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Primary care trusts are asked to forward this to relevant clinics.
Yours faithfully
Ian Holloway
Pharmaceutical Assessor, DMRC
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)
Class 1 Drug Alert (Action now – including out of hours): Hospira UK Ltd - Temozolomide Hospira Capsules - EL (10)A/15 (148Kb)
DETAILS FOR SANDOZ TEMOZOLOMIDE
http://www.mhra.gov.uk/Publications/Safetywarnings/DrugAlerts/CON087890
Class 1 Drug Alert (Action now – including out of hours): Sandoz Ltd - Temozolomide Capsules - EL (10)A/16
DRUG ALERT
CLASS 1 MEDICINES RECALL
Action now – including out of hours
PATIENT LEVEL RECALL 09 July 2010 EL (10)A/16 Our ref: MDR 12-07/10
----------------------------------------------------------
Dear Healthcare Professional,
Sandoz Ltd
Temozolomide Capsules
EU/1/10/617/001,005,009,013,017,021
Batch number Strength Pack size First distributed
AX1222 5 mg 5 1 June 2010
AX2369 5 mg 5 8 June 2010
AX1223 20 mg 5 1 June 2010
AX1229 20 mg 5 8 June 2010
AX1208 100 mg 5 1 June 2010
AX1211 100 mg 5 8 June 2010
AX1212 140 mg 5 1 June 2010
AX1202 180 mg 5 1 June 2010
AX1200 250 mg 5 1 June 2010
Sandoz Ltd is recalling the above batches to patient level due to reports of broken capsules and leakage. We understand this product is normally supplied via hospitals and not from general practitioners or community pharmacy.
Pharmacists and clinics are requested to contact patients and ask them to return any stock of the above batches without further opening of the containers. If external contamination of the containers is suspected handle whilst wearing latex or nitrile gloves. Place the container in a polyethylene bag and seal prior to return.
Contact of the capsule contents with skin or mucosa should be avoided. In the event of such contact the area should be immediately and thoroughly washed with soap and water and medical advice sought promptly. In the case of eye contact remove from source of exposure then flush with copious amounts of water. If irritation persists or signs of toxicity occur, seek medical attention.
We understand that alternative product is available from other marketing authorisation holders. Patients should be advised to obtain an alternative prescription and replacement stock as soon as possible.
Pharmacists are asked to quarantine any remaining stock from these batches, package it thoroughly, as described above, and return it to your supplier for credit.
For medical information enquiries, stock return enquiries or concerns about possible contamination, please call Sandoz on 01276 698020 01276 698020 .
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Primary care trusts are asked to forward this to relevant clinics.
Yours faithfully,
Ian Holloway
Pharmaceutical Assessor, DMRC
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)
Class 1 Drug Alert (Action now – including out of hours): Sandoz Ltd - Temozolomide Capsules - EL (10)A/16 (137Kb)
Temozolomide recall in the UK.DETAILS FOR HOSPIRA TEMOZOLOMIDE
Class 1 Drug Alert (Action now – including out of hours): Hospira UK Ltd - Temozolomide Hospira Capsules - EL (10)A/15
DRUG ALERT
CLASS 1 MEDICINES RECALL
Action now – including out of hours
CLASS 1 MEDICINES RECALL 06 July 2010 EL (10)A/15 Our ref: MDR 03-07/10
----------------------------------------------------------
Dear Healthcare Professional,
Hospira UK Ltd
Temozolomide Hospira Capsules
EU/1/10/615/001 TO 024
Batch number Strength Pack size First distributed
L00828 5 mg 5 capsules 15 April 2010
L00829 20 mg 5 capsules 6 April 2010
L00831 100 mg 5 capsules 6 April 2010
L01031 250 mg 5 capsules 6 April 2010
Hospira UK Ltd is recalling the above batches to patient level due to reports of broken capsules and leakage. We understand this product is normally supplied via hospitals and not from general practitioners or community pharmacy.
Pharmacists and clinics are requested to contact patients and ask them to return any stock of the above batches without further opening of the containers. If external contamination of the containers is suspected handle whilst wearing latex or nitrile gloves. Place the container in a polyethylene bag and seal prior to return.
Contact of the capsule contents with skin or mucosa should be avoided. In the event of such contact the area should be immediately and thoroughly washed with soap and water and medical advice sought promptly. In the case of eye contact remove from source of exposure then flush with copious amounts of water. If irritation persists or signs of toxicity occur, seek medical attention.
We understand that alternative product is available from other marketing authorisation holders. Patients should be advised to obtain an alternative prescription and replacement stock as soon as possible.
Pharmacists are asked to quarantine any remaining stock from these batches, package it thoroughly, as described above, and return it to Hospira for credit. For contact with Hospira Customer Services please call 0800 028 7304 0800 028 7304 . If pharmacists have any concerns about possible external contamination, they should call Hospira UK Ltd on 01926 834 400 01926 834 400 to seek advice before returning the stock.
For medical information enquiries, please call Hospira UK Ltd on 01926 834 400 01926 834 400 Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Primary care trusts are asked to forward this to relevant clinics.
Yours faithfully
Ian Holloway
Pharmaceutical Assessor, DMRC
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)
Class 1 Drug Alert (Action now – including out of hours): Hospira UK Ltd - Temozolomide Hospira Capsules - EL (10)A/15 (148Kb)
DETAILS FOR SANDOZ TEMOZOLOMIDE
http://www.mhra.gov.uk/Publications/Safetywarnings/DrugAlerts/CON087890
Class 1 Drug Alert (Action now – including out of hours): Sandoz Ltd - Temozolomide Capsules - EL (10)A/16
DRUG ALERT
CLASS 1 MEDICINES RECALL
Action now – including out of hours
PATIENT LEVEL RECALL 09 July 2010 EL (10)A/16 Our ref: MDR 12-07/10
----------------------------------------------------------
Dear Healthcare Professional,
Sandoz Ltd
Temozolomide Capsules
EU/1/10/617/001,005,009,013,017,021
Batch number Strength Pack size First distributed
AX1222 5 mg 5 1 June 2010
AX2369 5 mg 5 8 June 2010
AX1223 20 mg 5 1 June 2010
AX1229 20 mg 5 8 June 2010
AX1208 100 mg 5 1 June 2010
AX1211 100 mg 5 8 June 2010
AX1212 140 mg 5 1 June 2010
AX1202 180 mg 5 1 June 2010
AX1200 250 mg 5 1 June 2010
Sandoz Ltd is recalling the above batches to patient level due to reports of broken capsules and leakage. We understand this product is normally supplied via hospitals and not from general practitioners or community pharmacy.
Pharmacists and clinics are requested to contact patients and ask them to return any stock of the above batches without further opening of the containers. If external contamination of the containers is suspected handle whilst wearing latex or nitrile gloves. Place the container in a polyethylene bag and seal prior to return.
Contact of the capsule contents with skin or mucosa should be avoided. In the event of such contact the area should be immediately and thoroughly washed with soap and water and medical advice sought promptly. In the case of eye contact remove from source of exposure then flush with copious amounts of water. If irritation persists or signs of toxicity occur, seek medical attention.
We understand that alternative product is available from other marketing authorisation holders. Patients should be advised to obtain an alternative prescription and replacement stock as soon as possible.
Pharmacists are asked to quarantine any remaining stock from these batches, package it thoroughly, as described above, and return it to your supplier for credit.
For medical information enquiries, stock return enquiries or concerns about possible contamination, please call Sandoz on 01276 698020 01276 698020 .
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Primary care trusts are asked to forward this to relevant clinics.
Yours faithfully,
Ian Holloway
Pharmaceutical Assessor, DMRC
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)
Class 1 Drug Alert (Action now – including out of hours): Sandoz Ltd - Temozolomide Capsules - EL (10)A/16 (137Kb)
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