MHRA Class 4 Medicines Defect Notification: Pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg Capsules, (Jubilant Pharmaceuticals NV)
MHRA Class 4 Medicines Defect Notification: Brilique 90mg tablets (G Pharma Ltd)
Drug alert number: EL(25)A/19
Date issued: 29 April 2025
Jubilant Pharmaceuticals BV has informed the Medicines and Health products Regulatory Agency (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.
DMRC reference number:DMRC-34966203
Company name: Jubilant Pharmaceuticals NV
Product name: Brilique 90mg tablets PLPI: 16369/2052
Medicine Details
Pregabalin 25mg capsules
PL19156/0145
Active ingredient: Pregabalin
SNOMED code: 7888911000001104
GTIN: 089028053339
Pregabalin 50mg capsules
PL19156/0146
Active ingredient: Pregabalin
SNOMED code: 7890111000001103
GTIN: 08902805203346
Pregabalin 75mg capsules
PL19156/0147
Active ingredient: Pregabalin
SNOMED code: 7890411000001108
GTIN: 08902805203353
Pregabalin 100mg capsules
PL19156/0148
Active ingredient: Pregabalin
SNOMED code: 7890711000001102
GTIN: 08902805203360
Pregabalin 150mg capsules
PL19156/0149
Active ingredient: Pregabalin
SNOMED code: 7891011000001108
GTIN: 08902805203377
Pregabalin 200mg capsules
PL19156/0150
Active ingredient: Pregabalin
SNOMED code: 7891511000001100
GTIN: 08902805203384
Pregabalin 225mg capsules
PL19156/0151
Active ingredient: Pregabalin
SNOMED code: 13075911000001106
GTIN: 08902805203391
Pregabalin 300mg capsules
PL19156/0152
Active ingredient: Pregabalin
SNOMED code: 7891911000001107
GTIN: 08902805203407
Affected Lot Batch Numbers
See Download Document for batch numbers
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 2025.
Advice for healthcare professionals
Healthcare professionals are advised to exercise caution when handling the listed products and ensure that they are stored accordingly and in line with the guidance for the storage of Prescription Only Medicines (POM).
Additionally, healthcare professionals are reminded to only dispense these products when the pharmacy team receives a suitable prescription prescribed by a qualified health professional.
See full alert here.
Advice for patients
This issue is about missing information on the outer carton (box). The medicine itself is not affected and therefore patients do not need to take any action.
These products will have been prescribed and dispensed by the qualified healthcare professional(s) responsible for your care. If you have any concerns, please speak with your pharmacy team in the first instance. If you have concerns about a medicine you may be using, please contact your healthcare professional. 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 medical information enquiries please email safety.uk@lambda-cro.com or telephone 0080089013370
For stock control enquiries please email JPUK.Customerservice@jubl.com, or telephone 01233 552293
