Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: Synalar GEL 30g, Synalar GEL 60g (fluocinolone acetonide 0.025%), Reig Jofre UK |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that it has been identified that certain batches of Synalar Gel 30g and 60g (fluocinolone acetonide 0.025%) 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. The affected batches are:
- Synalar Gel 30g (batch number: L303A, L304A, L401A, L403A, L404A)
- Synalar Gel 60g (batch number: L301A, L402A)
Synalar gel is indicated for seborrhoea, seborrhoeic dermatitis and psoriasis of the scalp. It may also be applied to inflammatory dermatoses on other parts of the body.
Reig Jofre UK is 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 is unable to provide a specific date for when new stock will be available.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-synalar-gel-30g-synalar-gel-60g-fluocinoline-acetonide-0-dot-025-percent-reig-jofre-uk-el-25-a-slash-16
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Wednesday, Apr 9, 2025
Issued at HKT 16:15
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