Pfizer (Australia) STERILE POTASSIUM CHLORIDE CONCENTRATE potassium chloride 750 mg/10 mL injection ampoule, Pfizer Australia Pty Ltd, CON-872
Product name
Pfizer (Australia) STERILE POTASSIUM CHLORIDE CONCENTRATE potassium chloride 750 mg/10 mL injection ampoule
Sponsor name
Pfizer Australia Pty Ltd
Batches
B699, B723, B764, B765, B708
Consent start
Consent no.
CON-872
Standard
Paragraph 11(2)(f) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product does not conform with the requirements of Paragraph 11(2)(f) of TGO
91 in that the carton label does not state the weight of the active ingredient
in the stated volume of fill of the injection in the container.
Conditions imposed
A Customer letter identical to that provided to the Therapeutic Goods
Administration on 29 September 2021 will be supplied with each affected
batch.
Therapeutic product type
Prescription medicines