Pfizer issues recall of 4.2million drug packets due to risk of poisoning for failing to meet child-resistant packaging standards
Pharma-giant Pfizer is recalling millions of packages of its migraine medication after it was found they did not meet child-resistant packaging standards.
Packets of Nurtec ODT, a drug available via prescription, were deemed to have unsafe packaging by the US Consumer Product Safety Commission (CPSC). If a child were to break into the packaging and swallow the pills, the could be poisoned.
Pfizer stressed there is no need to return Nurtec ODT packages, as the notice is only related to the packaging. The drug is still safe when used correctly.
Rimegepant, sold under brand names including Nurtec ODT, is used to prevent and treat migraines in adults. It first received Food and Drug Administration (FDA) approval in 2020.
The drug, adverts for which featured Khloe Kardashian, works by blocking CGRP receptors.
CPSC recommended that customers ‘immediately secure the recalled product out of the sight and reach of children’.
The New York City-based firm is issuing a voluntary recall of packets of its Nurtec ODT 75 mg orally disintegrating tablets.
These are sold in cartons containing one blister card of eight tablets, but said it was not aware of any child poisonings occurring as a result of the packaging.
The packaging does not meet the child-resistant requirements for oral prescription drugs, as mandated by the Poison Prevention Packaging Act (PPPA).
This ‘pos[es] a risk of poisoning if the contents are swallowed by young children’, said the CPSC.
The CPSC uses the term ‘recall’ to mean ‘any repair, replacement, refund, or notice/warning program’.
The public body recommended that customers ‘immediately secure the recalled product out of the sight and reach of children’.
Once the product is out of sight and reach of children, ‘consumers can continue to use it as directed’.
Pfizer is issuing child-resistant pouches to store the medication in free of charge, and people in possession of the medication can contact Pfizer at 1-800-879-3477 to request one.
The tablets have been sold in pharmacies across the US from December 2021 through March 2023.
Pharmacists have been told to put the pills into vials with child-resistant lids when filling patient prescriptions.
Every year, more than half a million children below the age of five experience a potential poisoning related to medicines.
Among young children, 95 percent of medication-related poisoning visits to emergency departments are due to a child ingesting medication while unsupervised.
Last year in March, Pfizer recalled three blood pressure pills, including Accuretic and two generic brand, after finding they contained elevated levels of nitrosamines — a cancer causing impurity also found in cured meats.