Class 2 medicines recall – Action within 48 hours: Co-amoxiclav powder for oral suspension

A Class 2 medicines recall has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for certain batches of both strengths of co-amoxiclav suspension by Sandoz Ltd

DRUG ALERT

Class 2 medicines recall – Action within 48 hours

Ref: EL (19) A/12

Date 13 May 2019

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

Co-amoxiclav powder for oral suspension 250 mg/62.5 mg/5 ml
(Manufactured by Sandoz Ltd  )

PL 04416/0514

PL 04416/0515

A Class 2 medicines recall has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for certain batches of co-amoxiclav suspension (Amoxicillin trihydrate/Potassium Clavulanate) as listed in the table below.

Sandoz Ltd has reported a possible packaging issue relating to poor adherence of the bottle seal which may lead to clumping of the powder inside the bottle. This may cause the medicine to be ineffective due to degradation of the clavulanic acid in the powder.

Community pharmacists and their teams should stop supplying the above batches of this medicine; quarantine any remaining stock and return to the original supplier.

Further information can be found on the MHRA section on the GOV.UK website.

Produced by the NPA Pharmacy Services team May 2019.