Support Alert

Class 4 medicines defect information: some batches of Gentamicin Sulphate Active Pharmaceutical Ingredient (API)

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 drug alert (caution in use) for specified batches of Gentamicin Sulphate Active Pharmaceutical Ingredient (API) used to manufacture the finished products which are detailed in the MHRA alert. This is because products may contain higher than expected levels of histamine, which is a residual from the manufacturing process

Further details of the affected batches and action to take are available on the MHRA website.

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