Multiple sclerosis drug recalled over unacceptable 'variability'

A manufacturer has recalled a medicine used to treat multiple sclerosis (MS) “as a precautionary measure”, the pharmacy negotiator has announced.

Multiple sclerosis
It advised pharmacists to stop supplying the affected batches “immediately”

Community Pharmacy England (CPE) yesterday (August 19) said that four batches of Fingolimod 0.5 mg hard capsules have been recalled by their manufacturer Glenmark Pharmaceuticals Europe Ltd.

The fingolimod hydrochloride medicine is a disease modifying therapy (DMT) for “highly active” relapsing MS, according to the MS Society.

The manufacturer is recalling the batches “as a precautionary measure” after testing showed “out of specification results”, according to a medicines defect notice issued by the Medicines and Healthcare products Regulatory Agency (MHRA), CPE said.

Read more: Three HRT medicines discontinued amid ADHD drug recall

This included “variability of the capsule contents beyond permitted levels”, the alert added.

It advised pharmacists to stop supplying the affected batches “immediately”, quarantine “all remaining stock” and return it to their supplier.

But it stressed that patients should continue to take medicines from the batches “as prescribed”.

Read more: Co-codamol tablets recalled over two-year expiry date error

The affected batches, all of which have a pack size of 28 capsules, are:

  • 1306526, expiring May 31 2025
  • 1306528, expiring May 31 2025
  • 1400709, expiring November 30 202
  • 1400710, expiring November 30 2025

CPE last month announced that three hormone replacement therapy (HRT) drugs had been discontinued, while 39 batches of an ADHD drug had been recalled. 

And in April, a batch of co-codamol tablets was recalled as a “precautionary measure” after the wrong expiry date was printed on packaging. 

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Costanza Potter

Read more by Costanza Potter

Cos Potter joined C+D as its news editor in December 2022 but has been covering primary care news for over five years. After starting out at the pharmacy press in 2019, she worked at a GP title for several years before the pharmacy sector beckoned her back.

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