MHRA alert acetylcysteine injection

30th June 2010

Black particles have been found in a very small number of ampoules of acetlcysteine injection 200mg/mL (Aurum pharmaceuticals, Martindale livery, batch numbers 80455 and 90114).
The particles are carbonised material which forms if droplets of solution are present during sealing of the ampoules. Particles may be suspended in the solution, or may adhere to the inner wall of the ampoule neck.
In order to avoid stock shortages, these batches are not being recalled. The ampoules should be inspected as per normal parenteral practices and any affected ampoules should be discarded.

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