Sandoz, along with its affiliate Novartis Pharmaceuticals, has recalled selected blister packages over child-resistant packaging issue.
Image: Novartis headquarters in Basel, Switzerland. Photo: courtesy of Novartis AG.
The companies have recalled certain lots of product distributed in the US in pre-packaged blister card packages, after detecting that the packs are not in line with federal standards for child-resistant packaging.
After noticing the issue, the firms informed the US Consumer Product Safety Commission (CPSC) and Food and Drug Administration (FDA) that the blister packs at issue are not compliant for consumer home use.
Novartis said the recall has been initiated, as the blister packs are not child-resistant, and there are no quality or safety issues with the medicines for their intended use.
Sandoz products affected by the recall include Azithromycin, Donepezil ODT, Haloperidol, Imipramine, ISDN (Isosorbide dinitrate), Naratriptan, Ondansetron ODT, Ondansetron, Perphenazine and Risperidone ODT.
The recalled products include Azithromycin 250mg tablets in 50 count hospital unit dose blister packages, Donepezil ODT 5mg and 10mg in 30 count unit dose blister packs, and Haloperidol 0.5mg, 1mg, 2mg, 5mg and 10mg in 100 count hospital unit dose blister packages.
The recalled products also comprise of Imipramine 25mg and 50mg in 100 count hospital unit dose blister packages, ISDN10mg and 20mg in 100 count hospital unit dose blister packages, Naratriptan 2.5mg in 9 count unit dose blister packs and Ondansetron ODT 4mg and 8mg orally disintegrating tablets (ODT) in blister packs.
Sandoz’s other recalled products include Ondansetron 8mg tablets in blister packs of three tablets, Perphenazine 2mg, 4mg and 8mg in 100 count hospital unit dose blister packages, Risperidone ODT 0.5mg, 1mg, 2mg, 3mg and 4mg orally disintegrating tablets (ODT) in 28 count blister packs.
Novartis Pharmaceuticals products affected by the recall include Entresto (sacubitril/valsartan) tablets and Zofran ODT (ondansetron).
The recalled products include Entresto 24mg/26mg, 49mg/51mg and 97mg/103mg in 100 count tablet hospital unit dose blister packages and Zofran ODT 4mg and 8mg tablets in blister packs.
Sandoz is a generic pharmaceuticals and biosimilars division of Novartis Group, which markets its products in around 155 countries across the globe.