Pregabalin 25mg capsules
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-34966203
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Pregabalin 25mg capsules | PL19156/0145 | Pregabalin | 089028053339 |
Background: Jubilant Pharmaceuticals BV has informed the MHRA that the outer carton (box) of the product batches mentioned in this notification are missing the medicines legal classification for a Prescription Only Medicine ‘POM’. There is no risk to product quality or safety of the medicines because of this missing information, therefore the affected batches are not being recalled. The batches listed as ‘not yet distributed’ have also been packaged with the incorrect outer carton (box) and are missing the medicines legal classification for a Prescription Only Medicine ‘POM’. The MHRA, in discussion with the Department of Health and Social Care, considers these products critical for patients, therefore these batches will not be repackaged and continue to be distributed. They are therefore included in the notification and the expected distribution dates for these batches will take place from May 20