Particle.news

Betapharm Recalls Two Pantoprazol Batches Over Missing Release and Drug‑Release Deviation

Regulators have told pharmacies and wholesalers to quarantine and return the named packs, and no patient harm has been reported so far.

Overview

  • The recall, announced on Sept. 10–11, covers two Pantoprazol beta 40 mg magensaftresistente batches: CV250342 (30 tablets) and CV250344 (100 tablets).
  • Betapharm says some packs were released without the legally required sign‑off by a qualified person and tests found a deviation in the drug‑release specification for those batches.
  • Pharmacies and wholesalers have been instructed to block remaining stock and return affected packs through the supply chain, and apothecaries will be credited for returned items.
  • Consumers should have pharmacists check the batch number on their box or blister (look for “Ch.-B.”) and must not stop or change prescriptions without consulting a doctor or pharmacist.
  • Authorities including BfArM and the AMK are overseeing the recall, no patient‑level harm has been confirmed, and experts note a release‑deviation alone does not prove reduced efficacy or direct health risk.