The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a Class 4 medicines defect notification after being notified by Macarthys Laboratories Ltd T/A Martindale Pharma.
They alerted that several batches of the company’s Xaggitin XL Prolonged-release Tablets were found to contain the wrong number of tablets.
Manufacturer Macarthys Laboratories trades under the name of Martindale Pharma.
The manufacturing defect affects 17 batches of the methylphenidate hydrochloride-containing medication across various strengths (18mg, 27mg, 36mg, and 54mg).
Nine affected batches were distributed between February and May, while eight batches have yet to be distributed.
It has not yet been established if the pending batches are impacted.
Because Xaggitin XL is a critical medicine for patients managing ADHD, the MHRA confirmed that the affected batches will not be recalled or repackaged and will continue to be distributed to avoid supply disruptions.
The MHRA said: “The majority of reports are for missing tablets but extra tablets have also been reported.
“The defect appears to be impacting a low percentage of packs within a batch, impacting reconciliation of the Schedule 2 Controlled Drug in practices.”
The medicine watchdog urged pharmacies to physically check tablet quantities when receiving deliveries of the medicine and dispensing packs to patients, and to contact licensed@ethypharm.com if they need to break the tamper evident seal to do so.
Patients have been advised to continue to take the tablets prescribed by your doctor as the quality of the tablets is not impacted by this defect.
