Hiprex 1g tablets
What this means
The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.
Class 4 defect notification · DMRC- 39194203
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Hiprex 1g tablets | methenamine hippurate |
Batches (expiry): 251352/BA (04/2028), 251358/BA (04/2028), 252137/BA (04/2028), 252137/BB (04/2028), 251358/BB (04/2028)
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. Correct Braille Incorrect Braille