Class 2 Medicines Recall: Synalar GEL, Reig Jofre UK, EL(25)A/16
Class 2 Medicines Recall: Synalar GEL 30g, Synalar GEL 60g,(fluocinoline acetonide 0.025%) Reig Jofre UK,EL(25)A/16
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.
DMRC Number: DMRC-35165402
Company name: Reig Jofre UK
Product descriptions:
Synalar GEL 30g - PL: 44095/0004, SNOMED code: 2156911000001100, GTIN: 8435373700332
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| L303A | 31/03/2026 | 1 | 19/05/2023 |
| L304A | 30/04/2026 | 1 | 21/08/2023 |
| L401A | 31/03/2027 | 1 | 10/06/2024 |
| L403A | 31/05/2027 | 1 | 17/10/2024 |
| L404A | 31/05/2027 | 1 | 17/10/2024 |
Synalar GEL 60g - PL: 44095/0004, SNOMED code: 11507311000001100, GTIN: 8435373700349
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| L301A | 28/02/2026 | 1 | 11/07/2023 |
| L402A | 31/03/2027 | 1 | 17/10/2024 |
Brief description of problem:
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 to Healthcare Professionals:
Stop supplying the affected batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Advice to 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.
Company contacts for further information:
For medical information enquiries please contact Reig Jofre UK Medical Information on 0330 1359 434 or by email MedInfoUK@reigjofre.com.
To access the full recall: Class 2 Medicines Recall: Synalar Gel 30mg and Synalar Gel 60mg (fluocinolone acetonide 0.025%), Reig Jofre UK, EL(25)A/16