Class 2 MHRA Medicines Recall – Co-amoxiclav 125mg/31.25mg/5ml & 250mg/62.5mg/5ml powder for oral suspension (Sandoz Ltd)

Class 2 MHRA Medicines Recall – Co-amoxiclav 125mg/31.25mg/5ml & 250mg/62.5mg/5ml powder for oral suspension (Sandoz Ltd)

May 13, 2019

Drug alert number: EL (19) A/12
Date issued: 13th May 2019 

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 pharmacy level medicines recall, to be actioned within 48 hours, for certain batches of co-amoxiclav 125mg/31.25mg/5ml powder for oral suspension and 250mg/62.5mg/5ml powder for oral suspension.

Sandoz Limited is recalling the batches identified below from pharmacies as a precautionary measure due to 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.

Co-amoxiclav 125mg/31.25mg/5ml powder for oral suspension PL 04416/0514

Co-amoxiclav 250mg/62.5mg/5ml powder for oral suspension PL 04416/0515

Batch Number Expiry Date Pack Size First Distributed
  HT6202   Feb 2021   100ml   Sep 2018
  HT7923   Feb 2021   100ml   Jul 2018

Community pharmacy teams should stop supplying the above products/batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

To view the alert please visit the GOV.UK website.

Company contacts for further information

For stock control enquiries 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



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