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DRUG ALERT
CLASS 1 MEDICINES RECALLPATIENT LEVEL RECALL
| 09 July 2010 | EL (10)A/16 | Our ref: MDR 12-07/10 |
Dear Healthcare Professional,
Sandoz Ltd
Temozolomide Capsules
| 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.
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
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 
