Alert: Propantheline 15mg Tablets

The MHRA has issued a class 4 alert relating to an error in the patient information leaflet for Propantheline Tablets 15mg in Genesis Pharmaceuticals livery.

Chelonia Health Care Ltd has notified the MHRA that 10 batches of the 112 tablets pack size issued between January and June this year are affected. Section 6 in the PIL describes the product as being “pale pink in colour”, whereas the tablet is actually orange in colour.

“There is no risk to product quality or safety because of this issue. Therefore the affected batches are not being recalled,” says the MHRA.

Healthcare professionals should note the correct description of the tablets as “round and convex in shape, and orange in colour.” Patients need not take any action.

For medical queries, contact eupvg@genreg.eu (Tel: 020 7201 0421).

For stock control queries, contact info@genesis-pharma.com (Tel 020 7201 0400)

MHRA alert