Pfizer (Australia) STERILE POTASSIUM CHLORIDE CONCENTRATE potassium chloride 750 mg/10 mL injection ampoule, Bridgewest Perth Pharma Pty Ltd, CON-1132
Product name
Pfizer (Australia) STERILE POTASSIUM CHLORIDE CONCENTRATE potassium chloride 750 mg/10 mL injection ampoule
Sponsor name
Bridgewest Perth Pharma Pty Ltd
Batches
All relevant batches
Consent start
Consent no.
CON-1132
Standard
Subsection 9(4), Paragraph 10(4)(b), Paragraph 10(4)(f), Paragraph 11(2)(f), of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product(s) do not conform to the requirements of the Therapeutics Goods
Order No. 91 '“ Standard for labels of prescription and related medicines, in
that the product(s) do not have the text KCL oriented in the same direction as
other text on the label, the name of the medicine is less than 2.0mm, the term
Injection is not included as part of the dosage form on the ampoule label and
the active is expressed as mmol in mL not the stated weight.
Therapeutic product type
Prescription medicines