Medicines defect noticeMHRA
Pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg Capsules defect notice over a labelling error
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.
Check your product
Only products that match these details are covered. Have your pack in front of you.
8 identifiers listed for this notice.
Pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg Capsules
- Product licenceThe PL number on the carton.
- PL19156/0145
- PL19156/0146
- PL19156/0147
- PL19156/0148
- PL19156/0149
- PL19156/0150
- PL19156/0151
- PL19156/0152
What to do now
There is an error on the label, carton or patient leaflet for Pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg.
- Keep taking your medicine unless a healthcare professional tells you otherwise.
- Check the batch number and expiry date on your pack against the list on this page.
- If it matches, your pharmacist can swap it or arrange an alternative.
- Report suspected side effects to the MHRA Yellow Card scheme.
Why it matters. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
Symptoms and when to get help
Look out for
- a side effect you have not had before
- your condition not being controlled as well as usual
Get help urgently
- signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
- if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111
This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.
Replacements and prescriptions
If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself.
Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(25)A/19). Quoted as issued.
Summary
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.
The risk
DMRC reference number DMRC-34966203 Marketing Authorisation Holder
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.
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.
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.
Open the MHRA notice
Questions
Why has Pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg been recalled?
There is an error on the label, carton or patient leaflet for Pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
How do I know if my medicine is affected?
Compare the product licence on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.
What should I do now?
Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.
Do I need a new prescription?
If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself. Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.