Quality & complianceOfficial

SÚKL flags outdated leaflet in packs of Mycophenolic Acid Accord 180 mg tablets

🇨🇿 SÚKL · Wed 21 Oct 2026

Czech regulator reports that Accord's 120-tablet packs were supplied with an out-of-date patient information leaflet lacking updated adverse reactions.

The State Institute for Drug Control (SÚKL) in the Czech Republic published an information letter on 21 October 2026 for operators concerning a quality defect in Mycophenolic Acid Accord 180 mg gastro-resistant tablets, in packs of 120.

According to the notice, the marketing authorisation holder, Accord Healthcare Polska Sp. z o.o. of Poland, has informed the authority that an outdated version of the package leaflet was included in the packs. The leaflet does not contain the updated list of adverse reactions.

The item was issued by SÚKL's quality defects department and links to a 265 kB PDF letter. The web notice does not give batch numbers, the scale of the problem, or any instructions on recall, quarantine or other actions, so readers would need to consult the full letter.

Mycophenolic acid is the active substance in the product concerned. The notice does not discuss any clinical consequences of the leaflet error.

What it means for your team

  • Pharmacies and distributors in the Czech Republic should read the full SÚKL letter for affected batches and any required handling steps.
  • Regulatory affairs teams should note that the issue concerns leaflet version control, specifically the omission of updated adverse reaction information.
  • Quality and pharmacovigilance teams may wish to check that packaging and artwork change controls ensure the current leaflet version reaches the market.
  • The public notice provides no batch or action details, so no conclusions on scope should be drawn from it.

Official source: SÚKL ↗

Article written by VigiEye from the official source (SÚKL). AI-assisted; check the source before acting.

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