Class 2 Medicines Recall: Co-amoxiclav 125 mg/31.25 mg/5 ml and 25 mg/62.5 mg/5 ml Powder for Oral Suspension (MDR 24-05/19)

News By 13th May 2019

Class 2 Medicines Recall: Co-amoxiclav 125 mg/31.25 mg/5 ml and 25 mg/62.5 mg/5 ml Powder for Oral Suspension (MDR 24-05/19)

Product description

Co-amoxiclav 125 mg/31.25 mg/5 ml Powder for Oral Suspension; PL 04416/0514

Co-amoxiclav 250 mg/62.5 mg/5 ml Powder for Oral Suspension; PL 04416/0515

(Co-amoxiclav: Amoxicillin trihydrate/Potassium Clavulanate)

Batch number Expiry Date Pack size First distributed
HT6202 Feb 2021 100 ml September 2018
HT7923 Feb 2021 100 ml July 2018

Brief description of the problem

Sandoz Ltd. have been notified of a potential packaging problem relating to poor seal adherence which could cause clumping of the powder within the bottle. A poor bottle seal could lead to degradation of the clavulanic acid within the powder and could potentially render the product ineffective.

This recall is a precautionary measure. No complaints or adverse events relating to this defect have been received by the company from the UK market.

Wholesalers and healthcare professionals

Stop supplying the above noted batches of this product. Remaining stocks of the impacted batches should be quarantined and returned to your original supplier.

Contact details for further information

For enquiries relating to stock returns please contact Sandoz Limited Customer Services on 01276 698607 or email sales.sandoz-gb@sandoz.com

For medical information enquiries, please contact Sandoz Medical Information Team on 01276 698101 or email sandozgb@EU.propharmagroup.com