A batch of arthritis medication is being recalled due to a labelling error. The Medicines and Healthcare products Regulatory Agency (MHRA) announced on Wednesday that some packs had been distributed to pharmacies with incorrect labels.
The MHRA revealed that manufacturer Maxearn Limited had informed them that the label on an imported batch of Depo-Medrone had been “released to the market with an error”. They stated that the vial label contained incorrect information regarding volume and total vial content.
The MHRA clarified: “The 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 error could result in the administration of the incorrect dose.
“Maxearn has contacted their distributor, 32 packs have been distributed to pharmacies. The remaining units provided to the distributor have been quarantined.
“The error only impacts the parallel imported product repackaged by Maxearn, packs from other sources are not affected and should continue to be dispensed.”
Dep-Medrone is injected directly into joints and soft tissues for the treatment of rheumatoid arthritis, osteoarthritis, bursitis and similar inflammatory conditions.
The MHRA has assured patients there is no need for alarm after instructing healthcare providers to cease distribution of the affected batch immediately.
It added: “Maxearn can confirm 32 packs were released by the distributor. All other units have been held before onward distribution. Maxearn will arrange for customers who received these units to be contacted.
“Healthcare professionals who have been supplied this batch and have administered the medicine to patients should contact the patient to make them aware of this error and provide any relevant clinical advice.”
For those concerned, the MHRA clarified: “No further action is required by patients as this is a pharmacy and wholesaler level recall. Depo-Medrone is administered under the supervision of a healthcare professional. Patients who have received this batch will be contacted by your healthcare professional.
“Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.”