Pfizer is recalling greater than 4 million packages of the Nurtec ODT prescription migraine treatment over a threat of poisoning to kids as a result of a failure to fulfill child-resistant packaging security necessities.
The corporate is recalling round 4.2 million models of Nurtec ODT (rimegepant) 75mg orally disintegrating tablets, that are offered in packs of eight doses on a blister card, on Thursday, the U.S. Shopper Product Security Fee stated. Anybody affected will be capable of receive a free child-resistant pouch to retailer the product, the fee stated.
The prescribed drugs are required to be in child-resistant packaging, as mandated within the Poison Prevention Packaging Act, the security fee stated.
“The packaging of the merchandise is just not little one resistant, posing a threat of poisoning if the contents are swallowed by younger kids,” it warned.
Shoppers had been instructed to “instantly safe the recalled product out of the sight and attain of kids and get in touch with Pfizer for a free little one resistant pouch to retailer the product.”
As soon as customers have secured the drug within the pouch, they’ll proceed to make use of it as directed, the fee stated.
As of Thursday, no incidents had been reported in reference to the problem, the security fee stated.
Nurtec ODT shared information of the recall on Twitter and posted a press release to its web site saying Pfizer had “just lately decided that Nurtec ODT packaging doesn’t meet the child-resistant packaging necessities for oral pharmaceuticals, probably posing a threat of hurt if the contents are swallowed by younger kids.”
Whereas sufferers will nonetheless be capable of maintain the product as soon as they’ve obtained child-resistant pouches to retailer it in, Nurtec ODT famous that the security fee “makes use of the time period ‘recall’ to explain any restore, substitute, refund, or discover/warning program.”
Nurtec ODT stated Pfizer was working to create new packaging for the migraine treatment to adjust to child-resistant packaging necessities. Within the meantime, it stated pharmacists would place the the blister packages into vials with child-resistant lids when filling affected person prescriptions.
The drug was distributed at pharmacies nationwide as a prescribed drugs from Dec. 2021 by means of March 2023, the security fee stated.
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