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Class 4 alert for hyoscine butylbromide 20mg from Morningside Healthcare

Single batch affected by wrong PIL

November 22nd 2022

Tagged: MHRA alert

By Charles Gladwin

Morningside Healthcare Ltd has informed the MHRA of an error with the Patient Information Leaflet (PIL) packaged in its Hyoscine Butylbromide 20 mg Film-coated Tablets. Some packs within a single batch may contain a PIL for Midodrine Hydrochloride 2.5mg/5mg Tablets.

The affected batch is:

  • Batch number: 22237001
  • Pack size: 100
  • Expiry date: 04/2025
  • First distributed: 28/09/2022

As there is no risk to product quality and efficacy, the affected batch is not being recalled. Packs should be checked when dispensing the affected batch; if the wrong PIL is present it should be replaced with a copy of the correct PIL which can be downloaded and printed from https://www.medicines.org.uk/emc/files/pil.13314.pdf.

For medical information enquiries, contact [email protected] or call 0116 478 0322. For all stock enquiries, contact 0116204595.