DEXAMETHASONE VIATRIS dexamethasone phosphate (as dexamethasone sodium phosphate) 8 mg/2 mL solution for injection vial, Alphapharm Pty Ltd, CON-1064
Product name
DEXAMETHASONE VIATRIS dexamethasone phosphate (as dexamethasone sodium phosphate) 8 mg/2 mL solution for injection vial
Sponsor name
Alphapharm Pty Ltd
Consent start
Consent no.
CON-1064
Standard
The product does not meet the pH requirements of British Pharmacopoeia
Non-compliance with standard
The product does not meet the pH requirements in the monograph
Conditions imposed
1. A 'Dear Healthcare Provider' letter identical to that provided to the
Therapeutic Goods Administration on 15 July 2022 will be supplied with each
affected batch
2. The TGA must be inform immediately by writing to the decision delegate if any
batch of the product(s) is analysed and the results obtained for pH are greater
than or equal to pH 9.0.
Therapeutic product type
Prescription medicines