Labelling Change

HPS Pharmacies wish to advise that Pfizer has changed the labelling on their potassium chloride ampoules as follows:

Sterile Potassium Chloride Concentrate Ampoules
Potassium chloride 10mmol/10mL
ARTG 10793

The change relates to the expression of strength. The new artwork on the outer packaging states the strength of potassium chloride in mg/mL only, as shown below.

Pfizer acknowledges that this presents a potential safety risk and is taking action to address this issue. Revised artwork with the strength of potassium chloride expressed in mmol/mL is expected in early 2022.

There has been no change to the formulation or concentration, and no change to the labelling on individual ampoules.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Pfizer on 1800 675 229 or your pharmacist at HPS Pharmacies.

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