MHRA Class 2 Medicines Recall: Synalar GEL 30g & Synalar GEL 60g, (fluocinoline acetonide 0.025%) Reig Jofre UK

MHRA Class 2 Medicines Notification: Synalar GEL 30g, Synalar GEL 60g,(fluocinoline acetonide 0.025%) Reig Jofre UK

Drug alert number: EL(25)A/16

Date issued: 08 April 2025

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 is recalling the batches as a precautionary measure. This recall is at the pharmacy and wholesaler level.

DMRC reference number:DMRC-35165402

Company name: Reig Jofre UK

Medicine Details

Product name: Synalar GEL 30g (PL: 44095/0004)

SNOMED code: 2156911000001100

Active ingredient: Fluocinolone Acetonide 0.025%

Product name: Synalar GEL 60g (PL: 44095/0004)

SNOMED code: 11507311000001100

Active ingredient: Fluocinolone Acetonide 0.025%

Background

It has been identified that the batches listed in this notification of Synalar Gel 30g and 60g contain a residual solvent (benzene) at a level exceeding the ICH limit of 2ppm. This solvent has been identified from one of the excipients in the product, carbomer 940, and the theoretical results from the initial investigation prompted the testing of the retention samples. These results have shown some batches are within the limit, whilst some are over the 2ppm limit.

Reig Jofre UK are recalling all these affected batches as a precautionary measure. This recall is at pharmacy and wholesaler level. It is only the specific Synalar Gel batches listed in this notification that are affected. All other presentations of Synalar (Ointment and Cream) are not affected. Due to this recall, there will be a temporary shortage of Synalar Gel and Reig Jofre UK are unable to provide a specific date for when new stock will be available.

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.

View the full alert here.

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.

Additional information

For medical information enquiries please contact Reig Jofre UK Medical Information on 0330 1359 434 or by email MedInfoUK@reigjofre.com.

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