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DRUG ALERT: Augmentin powder for reconstitution

There is an error on the carton of all batches of Augmentin Intravenous powder for reconstitution (co-amoxiclav) 600mg, 10 vial packs (PL00038/0320), first distributed in December 2003 (GlaxoSmithKline).

The carton states “dissolve vial contents in 20ml of water.” The product should be dissolved in 10ml of water.

The company says that the whole dose of this product should be administered and it is stable in volumes of water over 20ml. The information is correct on the pack leaflet and in practice it is not possible to add 20ml water to a vial.

GlaxoSmithKline is continuing to distribute this product and expects stock with the correct cartons to be available from July.

Further details from GlaxoSmithKline on 0800 221 441.

Medicines and Healthcare products Regulatory Agency PDF (25K)