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Sandoz Co-Amoxyclav S 156mg/5ml POS and Sandoz Co-Amoxyclav SF 312mg/5ml POS, Amoxicillin, Clavulanic Acid (Sandoz)


Urgent Medicine Recall (Class B, Type 2)

Dear Healthcare Professional

sandoz co-amoxyclav recall

Sandoz SA (Pty) Ltd in collaboration with the South African Health Products Regulatory Authority (SAHPRA) are initiating a Class B, Type 2 recall on the above mentioned batches of Sandoz Co-Amoxyclav S 156mg/5ml 100ml Powder for Oral Suspension (POS) and Sandoz Co-Amoxyclav SF 312mg/5ml 100ml POS.

Sandoz Co-Amoxyclav S 156mg/5ml POS and Sandoz Co-Amoxyclav SF 312mg/5ml POS are both a combination of the penicillin-class antibiotic Amoxicillin and the beta lactamase inhibitor Clavulanic Acid. The combination is used in the treatment of upper respiratory tract infections, lower respiratory tract infections, urinary tract infections and skin/soft tissue infections.

The recall is instituted due to the potential risk of some containers having defective primary packaging, which results in poor container sealing. The defective seal will lead to the formation of easily detectable lumps in the powder along with discoloration as the active ingredients degrade due to moisture ingress. Degradation of the active ingredients may result in sub-therapeutic dose delivery for patients treated with the contents of an inadequately sealed container.

In the interest of patient safety, we request that you immediately return all units on hand for the batches mentioned above to your supplying wholesaler or distributor for a full credit. Your cooperation will be greatly appreciated and we apologize for any inconvenience caused. Should you have any queries, kindly contact the Sandoz Customer Call Centre on 0861 SANCAL or 0861 726225.

Sandoz SA (Pty) Ltd PO Box 154, Isando 1600 72 Steel Rd, Spartan Kempton Park, 1619 Gauteng South Africa Tel +27 (0) 11 929 9000 Fax +27 (0) 11 929-9195 Reg No: 1990/001979/07

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Click here to visit the Sandoz website..
Contact: Dr Dewald Kilian,
Telephone: +27 (0) 11 929 9000
Date: Monday, May 27, 2019