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Type of Product Medicine
TGA Recall Reference RC-2016-RN-01523-1
Product Name/Description Dilantin (phenytoin sodium) 30 & 100 mg capsule bottles and Dilantin (phenytoin) Infatabs 50 mg tablet bottle

Dilantin (phenytoin sodium) 30 mg capsule bottle
AUST R: 14306

Dilantin (phenytoin sodium) 100 mg capsule bottle
AUST R: 14305

Dilantin (phenytoin) Infatabs 50 mg tablet bottle
AUST R: 14308

Multiple lots affected
Recall Action Level Consumer
Recall Action Classification Class II
Recall Action Commencement Date 2/12/2016
Responsible Entity Pfizer Australia Pty Ltd
Reason/Issue It has been identified that bottles of Dilantin may have been supplied with child-resistant caps that may not engage or otherwise be properly secured. For more details, please see https://www.tga.gov.au/alert/phenytoin-dilantin-bottles-capsules-and-tablets .
Recall Action Recall for Product Correction
Recall Action Instructions Pfizer is advising pharmacists to confirm that the Child Resistant Closure is engaged/secured and hand tighten the cap, as needed, before dispensing to patients. Any bottle where the Child Resistant Closure cannot be engaged/secured after hand tightening the cap should not be dispensed. Pfizer is also advising doctors of this issue. Pharmacists and doctors are being requested to communicate to patients who may have been dispensed Dilantin to inform them of the importance of securing the Child Resistant Closure. If a patient cannot engage/secure the Child Resistant Closure, they should return the bottle to their pharmacy and it will be replaced. Pharmacies are to return any affected bottles to the wholesalers they purchased from for credit.
Contact Information 1800 675 229 - Pfizer