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)
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.
MDR Number
MDR 24-05/19
Company name
Sandoz Ltd.
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
Additional information
We do not anticipate any shortages of this product on the market This precautionary recall is related to two batches only.
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS Regional teams are asked to forward this to relevant clinics, general practitioners and community pharmacists.
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