Notice regarding recall to provide child-resistant pouches for Nurtec ODT:
- Pfizer recently determined that the previous Nurtec ODT packaging did not meet the child‑resistant packaging requirements for oral prescription drugs. Pfizer, in cooperation with the U.S. Consumer Product Safety Commission (CPSC), voluntarily implemented a CPSC‑approved recall of Nurtec ODT to provide patients with free child‑resistant pouches in which to store their Nurtec ODT. CPSC uses the term "recall" to describe any repair, replacement, refund, or notice/warning program.
- This notice is related to the packaging of Nurtec ODT and does not change the established safety profile of the drug when used as prescribed for its intended uses. There is no need to return Nurtec ODT packages.
- As of March 2023, Pfizer has identified and tested new packaging that meets the child‑resistant requirements for oral prescription drugs & began distributing this new packaging. This will be the only packaging distributed moving forward.
- Pfizer informed the U.S. CPSC and U.S. FDA that recent testing by Pfizer indicates the new packaging meets the required level of child‑resistant effectiveness as specified in the Poison Prevention Packaging Act (PPPA), which is administered by the CPSC.
What Nurtec ODT patients should do:
- Patients should continue to use Nurtec ODT as prescribed by their healthcare provider.
- Patients will continue to have access to Nurtec ODT through their pharmacies. Pharmacists have been informed that our updated packaging utilizes a perforated blister, where the previous packaging did not. There is no new special handling required.
- Pharmacists will no longer be placing Nurtec ODT blister packages into vials with child‑resistant lids when filling prescriptions.
- If you have any of the previous packaging (identifiable by the non‑perforated blister), keep it in the pharmacy‑supplied vial or Pfizer‑supplied pouch.
- Patients also should store Nurtec ODT in a safe location, out of the reach and sight of children.
- Please contact 1-800-879-3477 Monday through Friday 9:00 a.m. to 7:00 p.m. EST or visit Contact Us | Pfizer to request a child-resistant pouch in which to store the medication.
- For more information, patients can speak to their pharmacist or healthcare provider.