The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 recall, hameln pharma ltd is initiating a recall of a specific batch of Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion as a precautionary measure. This is due to an increased presence of visible crystalline particles within the solution, identified during ongoing re-inspection of retained samples.
Further information, advice and details of the affected batch can be found on the MHRA website.