Novartis and Sandoz are recalling several blister packaged prescription medications because they fail to meet child-resistant closure requirements as required by the Poison Prevention Package Act. The companies have received one report of a child consuming the antipsychotic haloperidol from a blister pack.
The recall affects about 470,000 units and includes drugs packaged with 3 to 10 tablets per blister card. The blister packs were designed for use in hospitals but some were sent to retail pharmacies and were likely dispensed for in-home use.
Novartis products affected by the recall include the anti-nausea drug Zofran ODT (ondansetron) 4mg and 8 mg; and the heart failure treatment Entresto (sacbitril/valsartan) 24/26mg, 49/51mg; and 97/103mg.
Sandoz products affected by the recall include the antibiotic Azithromycin Tablets 250mg; the Alzheimer’s treatment Donepezil ODT Tablets 5mg and 10mg; Haloperidol Tablets 0.5mg, 1mg, 2mg, 5mg, and 10mg; Imipramine HCl Tablets 25mg and 50mg; the heart failure treatment Isosorbide Dinitrate Tablets 10mg and 20mg; the migraine headache drug Naratriptan Tablets 2.5mg; anti-nausea drugs Ondansetron Tablets 8mg; and Ondansetron ODT 4mg and 8mg; and the antipsychotics Perphenazine Tablets 2mg, 4mg, 8mg, and Risperidone ODT Tablets 1mg, 2mg, 3mg, and 4mg.
Consumers who have affected blister cards should keep them out of sight and reach of children. Once the packages are secured, patients should continue to take the medications as prescribed. Novartis is also offering consumers child-resistant re-sealable pouches to sore their medications. For information, contact the company at 888-669-6682.