DILANTIN PAEDIATRIC SUSPENSION phenytoin 30 mg/5 mL oral liquid bottle, Viatris Pty Ltd, CON-975
Product name
DILANTIN PAEDIATRIC SUSPENSION phenytoin 30 mg/5 mL oral liquid bottle
Sponsor name
Viatris Pty Ltd
Batches
All batches released for supply from 29 July 2022 until 31 December 2023
Consent start
Consent no.
CON-975
Standard
The product does not conform with the requirements of ' European Pharmacopoeia (Ph. Eur.) general monograph 5.20 and British Pharmacopoeia (BP) general monograph SC IV Q for Elemental Impurities (i.e. adopted guideline of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3D Impurities - Guideline on Elemental impurities)
Non-compliance with standard
The product(s) exceed the ICH Q3D limits for Lead and Lithium for adults.
Conditions imposed
1. The levels of lead and lithium present in the product must not exceed the
Permitted Daily Exposure limits for children.
2. The products are supplied with the Dear Healthcare Practitioner letter
provided to the Therapeutics Goods Administration via email on 2 August
2022.
Therapeutic product type
Prescription medicines