Sandoz and Novartis Recall Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Closure Requirements

Certain blister card packages that do not meet US child-resistant packaging requirements are being recalled because they pose a risk of harm if the tablets are swallowed by children.
Jul 10, 2018
By Pharmaceutical Technology Editors

Sandoz and Novartis are recalling blister packages of certain prescription drugs after discovering certain blister card packages distributed in the United States do not meet US child-resistant packaging requirements, posing a risk of harm if the tablets are swallowed by children. The recall is dated July 6, 2018 and affects approximately 470,000 units, according to the US Consumer Product Safety Commission (CPSC) website. The firms have received one report of a child ingesting haloperidol from a blister pack. The companies note that there are no quality or safety issues with the medicines for their intended use, and that products dispensed in bottles are not affected. 

The recall from Novartis is for certain packages of Zofran ODT 4 mg and 8 mg (ondansetron) Orally Disintegrating Tablets (ODT) and for certain packages of ENTRESTO (sacubitril/valsartan) Tablets in 100-count hospital unit dose blister packages. More details about the lot numbers can be found on the Novartis website

The recall from Sandoz includes certain lots of Azithromycin (250 mg tablets in 50-count unit dose blister packages), Donepezil ODT (5 mg and 10 mg in 30-count hospital unit dose blister packages), Haloperidol (0.5 mg, 1 mg, 2 mg, 5 mg, and 10mg in 100-count hospital unit dose blister packages), Imipramine (25 mg and 50 mg in 100-count hospital unit dose blister packages), Isosorbide Dinitrate (ISDN) (10 mg and 20 mg in 100-count hospital unit dose blister packages), Naratriptan Tablets (2.5 mg in 9-count hospital unit dose blister packages), Ondansetron ODT (4 mg and 8 mg ODT), Ondansetron (8 mg tablets in blister packs of 3 tablets), Perphenazine (2 mg, 4 mg, and 8 mg in 100-count hospital unit dose blister packages), and Risperidone ODT (0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg ODT in 28-count blister packages). Affected lot numbers can be found on the Sandoz website

The affected blister packs were sold at clinics and pharmacies in the US as a prescribed medicine from September 2016 to June 2018. Patients should continue taking their medicine as directed by their physician, but they should secure the affected blister packs so that they are out of the sight and reach of children, announced the companies. As a corrective action, the companies will provide child-resistant, resealable pouches to store medication to consumers that request them. 

Sources: Sandoz, Novartis, CPSC

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