Class 4 Drug Alert (Caution in use): Aurum Pharmaceuticals Limited - Acetylcysteine 200 mg/ml Injection - EL(10)A/13 Rev 1

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Dear Healthcare Professional,

Aurum Pharmaceuticals Limited has informed us that black particles have been found in a very small number of ampoules from the above batches. Investigation has confirmed that the particles comprise 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 which case they may not be dislodged by shaking.

In order to avoid stock shortages, these batches are not being recalled. Provided this product is inspected as per normal parenteral practices, any affected ampoules should be detected and discarded.

For medical information enquiries please contact Aurum Pharmaceuticals Limited medical information on 01708 382791.

Recipients of this Drug Alert are requested to bring it to the attention of relevant professionals by copy of this letter.

Yours faithfully

Alison Bunce
Pharmaceutical Assessor, DMRC

 

MHRA Distribution (further recipients by cascade):
Regional contacts for NHS trusts and provider units
Chief pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special hospitals
Healthcare Commission for distribution to independent health care establishments
Primary care trusts (England)