A recall of several blister packaged prescription medications was initiated by Novartis and Sandoz due to the products failing to meet child-resistant closure requirements as per the Poison Prevention Packaging Act.
The recall affects approximately 470,000 units that include drugs packaged with 3 to 10 tablets per blister card. The blister packs were developed for use in hospitals, however some were sent to retail pharmacies and were likely dispensed for in-home use. At this time, 1 report of a child consuming haloperidol from a blister pack has been received.
The Novartis products include Zofran ODT (ondansetron) 4mg and 8mg; and Entresto (sacubitril/valsartan) 24/26mg, 49/51mg, and 97/103mg. The Sandoz products include Azithromycin Tablets 250mg; Donepezil ODT Tablets 5mg and 10mg; Haloperidol Tablets 0.5mg, 1mg, 2mg, 5mg, and 10mg; Imipramine HCl Tablets 25mg and 50mg; Isosorbide Dinitrate Tablets 10mg and 20mg; Naratriptan Tablets 2.5mg; Ondansetron Tablets 8mg; and Ondansetron ODT 4mg and 8mg; Perphenazine Tablets 2mg, 4mg, 8mg, and Risperidone ODT Tablets 1mg, 2mg, 3mg, and 4mg.
Consumers in possession of the affected blister cards should keep them out of sight and reach of children. Once the packages are secured, patients should continue to take their medications as directed.
The full list of recalled products with respective NDC numbers, Lot numbers, and expiration dates are listed here.
Novartis is offering patients child-resistant resealable pouches to store their medications. For more information contact the Company at 888-669-6682 or visit Novartis.com or Sandoz.com.