Class 4

Class 4 Medicines Defect Notification: Jubilant Pharmaceuticals NV, EL(25)A/19

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Class 4 Medicines Defect Notification: Pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg Capsules, Jubilant Pharmaceuticals NV, EL(25)A/19

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.

DMRC Number: DMRC-34966203

Company name: Jubilant Pharmaceuticals NV

Product descriptions: 

  • Pregabalin 25mg capsules - PL19156/0145, SNOMED code: 7888911000001104, GTIN: 089028053339
  • Pregabalin 50mg capsules - PL19156/0146, SNOMED code: 7890111000001103, GTIN: 08902805203346
  • Pregabalin 75mg capsules - PL19156/0147, SNOMED code: 7890411000001108, GTIN: 08902805203353
  • Pregabalin 100mg capsules - PL19156/0148, SNOMED code: 7890711000001102, GTIN: 08902805203360
  • Pregabalin 150mg capsules - PL19156/0149, SNOMED code: 7891011000001108, GTIN: 08902805203377
  • Pregabalin 200mg capsules - PL19156/0150, SNOMED code: 7891511000001100, GTIN: 08902805203384
  • Pregabalin 225mg capsules - PL19156/0151, SNOMED code: 13075911000001106, GTIN: 08902805203391
  • Pregabalin 300mg capsules - PL19156/0152, SNOMED code: 7891911000001107, GTIN: 08902805203407

Details of the affected batches: See Full Alert for batch numbers

Brief description of problem:

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 to 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.

Advice to 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.

Company contacts for further 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

To access the full recall: Class 4 Medicines Defect Notification: Pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg Capsules, Jubilant Pharmaceuticals NV, EL(25)A/19