Phenytoin (Dilantin) bottles of capsules and tablets

Recall for product correction - child-resistant caps may not function correctly

6 December 2016

Consumers and health professionals are advised that Pfizer Australia, in consultation with the TGA, has initiated a recall for product correction for bottles of phenytoin 30 mg capsules, 100 mg capsules and 50 mg tablets, which are marketed under the brand name Dilantin.

Front view of pill bottles of Phenytoin (Dilantin)

Dilantin is an anticonvulsant used to control epilepsy.

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. This creates a potential risk that a child could open a bottle and access the medicine.

If a child accidentally ingests Dilantin capsules or tablets, contact the Poisons Information Centre on 13 11 26.

To correct this issue, Pfizer Australia has initiated a recall for product correction to replace all bottles of Dilantin which have child-resistant caps that do not engage or otherwise are not properly secured.

Information for consumers

If you or someone you care for is taking Dilantin capsules or tablets, check the bottle to see if the cap is fully tightened and that the child-resistant feature functions correctly.

If the cap is fully tightened and the child-resistant feature functions correctly, you need not do anything further.

However, if you are unable to secure the cap, even after further tightening (the cap comes off without application of downward pressure), or if you are unsure, please return the product to your pharmacy for a replacement bottle.

You are reminded that all medicine should always be kept out of the reach of children, as stated on the product packaging.

If you have any questions or concerns about this issue, contact your health professional or Pfizer Australia on 1800 675 229.

Information for doctors

Pfizer Australia has written to doctors providing further information about this issue, including a patient communication letter.

If you are treating a patient who is taking Dilantin, please contact them either by phone or with the patient communication letter within the next three weeks to advise them of this issue.

Instruct them to check their bottle to ensure that the child-resistant cap is functioning correctly.

If the child-resistant cap does not function correctly, they should return the product to their pharmacy for a replacement bottle.

Reassure patients that there is no other concern regarding the quality or safety of these medicines, but consider reminding them of the importance of keeping all medicine out of the reach of children.

If you have any questions or concerns about this issue, contact Pfizer Australia on 1800 675 229.

Information for pharmacists

Pfizer Australia has written to pharmacists providing further information about this issue, including details of the process for this recall for product correction and a patient communication letter.

Pfizer Australia requests that you provide any patients who have been dispensed Dilantin with the patient communication letter.

Before dispensing new prescriptions for Dilantin or replacing returned bottles, please check to ensure that the child-resistant cap is functioning correctly. Any bottle with a child-resistant cap that is not functioning correctly should be returned to Pfizer Australia.

Reassure patients that there is no other concern regarding the quality or safety of these medicines, but consider reminding them of the importance of keeping all medicine out of the reach of children.

If you have any questions or concerns about this issue, contact Pfizer Australia on 1800 675 229.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.