Medicines recallMHRA
Synalar GEL 30g, Synalar GEL 60g,(fluocinolone acetonide 0.025%) Reig Jofre recalled over a quality concern
It has been identified that the batches of Synalar Gel 30g and 60g listed in this notification contain a residual solvent (benzene) at a level exceeding the ICH limit of 2ppm. Reig Jofre UK are recalling the batches as a precautionary measure. This recall is at the pharmacy and wholesaler level.
Check your product
Only products that match these details are covered. Have your pack in front of you.
17 identifiers listed for this notice.
Synalar GEL 30g, Synalar GEL 60g,(fluocinolone acetonide 0.025%) Reig Jofre 1
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- L303A
- L304A
- L401A
- L403A
- L404A
- L301A
- L402A
- ExpiryOn the carton, blister or label.
- 31/03/2026
- 30/04/2026
- 31/03/2027
- 31/05/2027
- 28/02/2026
- First distributedOn the product, its label or its packaging.
- 19/05/2023
- 21/08/2023
- 10/06/2024
- 17/10/2024
- 11/07/2023
What to do now
The MHRA has issued a notice about Synalar GEL 30g, Synalar GEL 60g,(fluocinolone acetonide 0.025%) Reig.
- 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. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.
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/16). Quoted as issued.
Summary
It has been identified that the batches of Synalar Gel 30g and 60g listed in this notification contain a residual solvent (benzene) at a level exceeding the ICH limit of 2ppm. Reig Jofre UK are recalling the batches as a precautionary measure. This recall is at the pharmacy and wholesaler level.
The risk
DMRC reference number DMRC-35165402 Marketing Authorisation Holder
Advice for healthcare professionals
Stop supplying the affected batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
No further action is required by patients as this is a pharmacy and wholesaler level recall.
Reig Jofre UK have confirmed that the patient risk due to this out of specification result is low based on the initial investigation and assessment, however the recall is a precautionary measure to mitigate any additional dispensing of the product batches.
Patients are advised not to stop any treatments without consulting your relevant healthcare professional. If you have any concerns in relation to the product or any side effects, please contact your pharmacist or GP for more information and assistance.
Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Advice for patients
No further action is required by patients as this is a pharmacy and wholesaler level recall.
Reig Jofre UK have confirmed that the patient risk due to this out of specification result is low based on the initial investigation and assessment, however the recall is a precautionary measure to mitigate any additional dispensing of the product batches.
Patients are advised not to stop any treatments without consulting your relevant healthcare professional. If you have any concerns in relation to the product or any side effects, please contact your pharmacist or GP for more information and assistance.
Patients who experience adverse reactions or have any questions about the 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 Synalar GEL 30g, Synalar GEL 60g,(fluocinolone acetonide 0.025%) Reig been recalled?
The MHRA has issued a notice about Synalar GEL 30g, Synalar GEL 60g,(fluocinolone acetonide 0.025%) Reig. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.
How do I know if my medicine is affected?
Compare the batch code, expiry and date code 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.