Synalar GEL 30g
What this means
The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.
Class 2 recall · DMRC-35165402
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Synalar GEL 30g | PL: 44095/0004 | Fluocinolone Acetonide 0.025% | 8435373700332 |
| Synalar GEL 60g | PL: 44095/0004 | Fluocinolone Acetonide 0.025% | 8435373700349 |
Batches (expiry): L303A (31/03/2026), L304A (30/04/2026), L401A (31/03/2027), L403A (31/05/2027), L404A (31/05/2027), L301A (28/02/2026), L402A (31/03/2027)
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 wh