PRA number
2016/15795
Published date
Product description
Dilantin (phenytoin sodium) 30mg capsule bottle - AUST R: 14306
Dilantin (phenytoin sodium) 100mg capsule bottle - AUST R: 14305
Dilantin (phenytoin) Infatabs 50mg tablet bottle - AUST R: 14308
Dilantin (phenytoin sodium) 100mg capsule bottle - AUST R: 14305
Dilantin (phenytoin) Infatabs 50mg tablet bottle - AUST R: 14308
Reasons the product is recalled
It has been identified that bottles of Dilantin have been supplied with child-resistant caps that may not engage or otherwise be properly secured.
The hazards to consumers
The contents of the bottles may be accessed and swallowed by children if the Child Resistant Closure mechanism is not engaged/secured.
What consumers should do
If a patient cannot engage/secure the Child Resistant Closure, they should return the bottle to their pharmacy for a replacement.
Consumers can contact Pfizer on 1800 675 229 for further information.
Consumers can contact Pfizer on 1800 675 229 for further information.
Supplier
Pfizer Australia
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.