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

DMRC reference number

DMRC-34966203

Marketing Authorisation Holder

Jubilant Pharmaceuticals NV

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.

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:

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

Download document

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