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Direct Healthcare Professional Communication (DHPC) on L-Arginine-Hydrochloride 21 % Braun (5 x 20 ml ampoules): Risk due to visible particles

Active substance: L-arginine hydrochloride

The company B. Braun Melsungen AG informs that visible particles have been found in the retained samples of several batches of the medicinal product L-Arginine Hydrochloride 21 % Braun. Before use, the ampoules should be checked visually to ensure that there are no particles. The concentrate for the preparation of an infusion solution should only be used if it is free of visible particles and the ampoule is undamaged and intact. Investigations have identified these particles as so-called "black burner" particles, which can occur when ampoules are sealed and can arise from carbonaceous components of a solution.

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