Defect warning issued for UTI drug

The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a class 4 defect notification for the urinary tract infection drug, hiprex 1 g tablets, due to an error related to the Braille embossing on the outer packaging.

Doncaster Pharma Limited informed the MHRA of the error on the outer packaging of parallel imported batches of hiprex 1 g tablets, which are listed below.

Affected lot batch numbers (pack size – 100 tablets):

• 251352/BA – expiring: 04/2028
• 251358/BA – expiring: 04/2028
• 252137/BA – expiring: 04/2028
• 252137/BB – expiring: 04/2028
• 251358/BB – expiring: 04/2028

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 correctly state the strength as 1g.

Doncaster Pharma Limited states that 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.

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.