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Sandoz - URGENT MEDICINE RECALL - SANDOZ CEFPODOXIME 40mg/5ml
URGENT MEDICINE RECALL: SANDOZ CEFPODOXIME 40mg/5ml Reg No A39/20.1.1/0397 (50ml and 100ml pack sizes)
Sandoz SA (Pty) Ltd in collaboration with the Medicines Control Council are initiating a Class 2, Type B recall on all batches of Sandoz Cefpodoxime 40mg /5ml (50ml and 100ml pack sizes).
Sandoz Cefpodoxime 40mg/5ml powder for oral suspension is an antibiotic used for short- term treatment of lower and upper respiratory tract infections in infants, children and adults.
The product is being recalled due to lower than expected efficacy, high unknown impurities, discolouration and formation of brownish agglomerates on certain batches of Sandoz Cefpodoxime 40mg/5ml tested during stability monitoring.
Use of the product may lead to weakened patient therapy through insufficient anti-infective treatment resulting in: a patient being contagious to others for a longer time, the development and spread of resistant bacterial strains, and significant therapeutic difficulties in eradication of respective bacteria.
In the interest of patient safety, Sandoz SA (Pty) Ltd request that you immediately return all batches of Sandoz Cefpodoxime 40mg/5ml stock without delay to your supplying wholesaler or distributor for full credit.
Sandoz SA (Pty) Ltd would like to thank you for your co-operation and apologise for any inconvenience caused.
Should you have any enquiries in this regard kindly contact the Sandoz Customer Call Centre 0861 SANCAL or 0861 726 225 during office hours and a technical support 24 hour call no 0768114744.
For full prescribing information please refer to package insert approved by Medical Regulatory Authority
Sandoz SA (Pty) Ltd PO Box 154, Isando 1600 Kempton Park, Gauteng South Africa Tel Fax +27 (0) 11 394 3084 Reg No: 1990/001979/07
Directors: R-A Bassoul (Canadian) J-C Dubos (French) M.M Paleja (Singaporean)
A Novartis Company
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Carla Urbani-Smith, (Responsible Pharmacist)
+27 (0) 11 929 9000
Tuesday, February 14, 2012