Cap problem leads to recall

recall regulatory

Anticonvulsant recalled due to issue with child-resistant caps

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.

According to advice provided by the TGA 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.

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.

Patients who have been dispensed Dilantin should be supplied with the patient communication letter.

Before dispensing new prescriptions for Dilantin or replacing returned bottles, pharmacists should 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,” the TGA and Pfizer are advising pharmacists.

Consumers are being advised that if they, or someone in their care, is taking Dilantin capsules or tablets, they should check the bottle to see if the cap is fully tightened and that the child-resistant feature functions correctly.

If they are unable to secure the cap, even after further tightening, or if they are unsure, consumers are to return the product to their pharmacy for a replacement bottle.

Contact Pfizer Australia on 1800 675 229 for any questions or concerns about this issue.

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