DILANTIN PAEDIATRIC SUSPENSION phenytoin 30mg/5mL oral liquid bottle, Pfizer Australia Pty Ltd, CON-321
Product name
DILANTIN PAEDIATRIC SUSPENSION phenytoin 30mg/5mL oral liquid bottle
Sponsor name
Pfizer Australia Pty Ltd
Batches
0L5679 0L5680
Consent start
Consent no.
CON-321
Standard
General requirements for Elemental Impurities of the British Pharmacopoeia (BP) or United States Pharmacopeia (USP) - International Conference on Harmonisation (ICH) Q3D Guideline on Elemental Impurities.
Non-compliance with standard
Lithium and lead levels in excess of the ICH Q3D permitted daily exposure limits
when dosed to patients with higher body weights (e.g. adults).
Conditions imposed
1. A 'Dear Healthcare Provider' letter identical to that provided by the TGA on
6 February 2019 will be supplied explaining the issues surrounding the products
and safe dosing levels for patients. 2. The Dear Healthcare provider letter will
be distributed with the affected batches as proposed in Pfizer's communication
with the TGA on 5 February 2019.
Therapeutic product type
Prescription medicines