MHRA Class 4 Medicines Defect Notification: Hiprex 1g tablets (Doncaster Pharma Ltd)

MHRA Class 4 Medicines Defect Notification: Hiprex 1g tablets (Doncaster Pharma Limited)

Drug alert number: EL(26)A/20

Date issued: 22 April 2026

Doncaster Pharma Limited has informed the MHRA of an error related to the Braille embossing on the outer packaging of the above mentioned parallel imported batches of Hiprex 1 g tablets (POM). It was identified that the embossed Braille text on the outer packaging incorrectly states the strength as 1mg. The printed text on the outer packaging, immediate packaging and Patient Information Leaflet (PIL) correctly state the strength as 1g.

DMRC reference number: DMRC-39194203

Marketing Authorisation Holder: Doncaster Pharma Limited

Medicine Details

Product name: Hiprex 1g tablets

PLPI: 56830/0284

Active ingredient: methenamine hippurate

SNOMED code: 44366111000001107

GTIN: N/A

Affected Lot Batch Numbers

Background

Doncaster Pharma Limited has informed the MHRA of an error related to the Braille embossing on the outer packaging of the above mentioned parallel imported batches of Hiprex 1 g tablets (POM). It was identified that the embossed Braille text on the outer packaging incorrectly states the strength as 1mg. The printed text on the outer packaging, immediate packaging and Patient Information Leaflet (PIL) correctly state the strength as 1g.

The correct Braille message should read:	The incorrect Braille message reads as:

Advice for healthcare professionals

The impacted products remain within specification and there is no issue with product quality. As a result, the affected batches are not being recalled.

Healthcare professionals should, if requested, explain the Braille errors to patients who rely solely on Braille when reading medicine cartons. As the products are supplied in a single strength, there is no risk of dosing errors arising from the Braille issue.

View the full alert here.

Advice for Healthcare Professionals to Provide to Patients:

No action is needed from patients, continue to take medication from these batches of tablets. The actions will be controlled by the healthcare professionals who prescribe or dispense the medication who will provide appropriate support at the time of dispensing, where required.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Additional information:

For all medical information enquiries and information on this product, please email regulatory@doncasterpharma.co.uk or quality.enquiries@doncasterpharma.co.uk, or telephone 01302 365 000.

For stock control enquiries, please email commercial@doncasterpharma.co.uk, or telephone 01302 365 000.