Class 2 Medicines Recall: Synalar Gel 30g, Synalar Gel 60g,(fluocinolone Acetonide 0.025%) Reig Jofre Uk,el(25)a/16
Synalar Gel Recall Summary Synalar Gel (fluocinolone acetonide 0.025%) in 30g and 60g sizes is being recalled in the United Kingdom because certain batches contain benzene, a residual solvent, at levels higher than the permitted limit of 2ppm. The recall affects specific batches and is being conducted at the pharmacy and wholesaler level as a precautionary measure.
- Recalling firm
- Synalar GEL 30g
- Reason
- 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.
- Classification
- Class II
- Category
- drug recall
- Country
- United Kingdom
- Agency
- UK Medicines and Healthcare products Regulatory Agency
- Recall date
- 2025-04-08
- Status
- Ongoing
- Distribution
- United Kingdom
Official recall notice from UK Medicines and Healthcare products Regulatory Agency
Recall details on Nibble Recalls: https://trynibble.app/recalls/0f73a66f-4b80-479d-b42e-be97fa403904