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The MHRA has issued a Class 4 medicines defect notification after “several batches” of ADHD medicine Xaggitin XL Prolonged-release Tablets were found to contain the wrong number of tablets.

Manufacturer Macarthys Laboratories, which trades as Martindale Pharma, notified the medicines watchdog of the issue, which affects 17 batches of the 27mg, 36mg and 54mg formulations of the methylphenidate hydrochloride-containing medicine.

Nine affected batches were distributed on dates between February and May this year, while eight have yet to be distributed.

It has not yet been established whether those lines yet to be distributed are affected by the issue. The MHRA said that because the medicine is “critical for patients” these batches “will not be repackaged and [will] continue to be distributed”. 

The MHRA explained further: “Multiple complaints of incorrect quantities of tablets in packs of Xaggitin XL Prolonged-release Tablets have been received.

“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 MHRA 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.