MHRA recalls medication with label error

An imported batch of Depo-Medrone has been released to the market with a label error that could result in the administration of the incorrect dose, according to a Medicines and Healthcare products Regulatory Agency (MHRA) class 2 medicines recall.

Batch number LG3883 Max 0943Y of Depo-Medrone 80mg/2ml suspension for injection (PLPI 20774/1666), first distributed on 13 May this year, has an incorrect label and been recalled by the MHRA. The vial label contains incorrect information regarding the volume and total vial content.

The vial over label incorrectly states that the total vial content is 40 mg in 1 ml, when the correct total vial content is 80mg in 2 ml (with a concentration of 40mg/ml of methylprednisolone acetate).

The MHRA advises pharmacists to stop supplying the affected batch immediately, quarantine all stock and return it to their supplier adding that if this batch has been administered to patients, they should alert the patient and provide any relevant clinical advice. It says no further action is required by patients as this is a pharmacy and wholesaler level recall.

Repackaged by Maxearn Limited, 32 packs have been distributed to pharmacies and the remaining units provided to the distributor have been held before onward distribution.

The error only impacts the parallel imported products repackaged by Maxearn Limited and packs from other sources are not affected and should continue to be dispensed, the recall notification says.