Novartis, Sandoz recall 12 medications over packaging concerns
WASHINGTON DC – Twelve medicines have been recalled in the United States by Sandoz Inc. and its affiliate Novartis Pharmaceuticals Corp., the companies said in a statement Friday, because their blister packaging does not meet US federal requirements for child resistance.
There are no quality or safety issues with the recalled medicines, and patients should continue to use them as prescribed, the companies said.
Recalled products include certain lots of risperidone ODT, donepezil ODT, naratriptan, ondansetron ODT, ondansetron tablets and Zofran ODT (ondansetron) in blister card packages. Additionally, azithromycin, haloperidol, imipramine, ISDN (isosorbide dinitrate), perphenazine and Entresto (sacubitril/valsartan) in hospital unit dose blister packaging have been recalled.
They are all prescription medications that were sold nationwide at clinics and pharmacies between September 2016 and June 2018, according to the US Consumer Product Safety Commission.
There has been one report of a child ingesting haloperidol from a blister pack, CPSC said in announcing the recall.
Products dispensed in bottles are not affected by this recall, according to the statement.
Patients should immediately safeguard the blister card packages and remove them from the sight and reach of children, the companies said. For additional help or information, patients can call 1-888-NOW-NOVA.
For azithromycin, the affected National Drug Code number for cartons is 0781-5776-69 and affected NDC number for blister packs is 0781-5776-06.
For donepezil ODT, the affected NDC numbers on cartons are 0781-5276-64 and 0781-5277-64, and the affected NDC numbers for blister packs are 0781-5276-06 and 0781-5277-06.
For haloperidol, the affected NDC numbers are 0781-1391-13, 0781-1392-13, 0781-1393-13, 0781-1396-13 and 0781-1397-13.
For imipramine, the affected NDC numbers are 0781-1764-13 and 0781-1766-13.
For ISDN (Isosorbide dinitrate), the affected NDC numbers are 0781-1556-13 and 0781-1695-13.
For naratriptan, the affected NDC number for cartons is 0781-5527-37, and the affected NDC number for blister packs is 0781-5527-06.
For ondansetron ODT, the affected NDC numbers for cartons are 0781-5238-64, 0781-5239-80 and 0781-5239-64, and the affected NDC numbers for blister packs are 0781-5238-06 and 0781-5239-06.
For ondansetron, the only affected NDC number is 0781-1681-33.
For perphenazine, the affected NDC numbers are 0781-1046-13, 0781-1047-13 and 0781-1048-13.
For risperidone ODT, the affected NDC numbers for cartons are 0781-5310-08, 0781-5311-08, 0781-5312-08, 0781-5313-08 and 0781-5314-08, and the affected NDC numbers for blister packs are 0781-5310-06, 0781-5311-06, 0781-5312-06, 0781-5313-06 and 0781-5314-06.
For Entresto (sacubitril/valsartan) tablets, the affected NDC numbers for cartons are 0078-0659-35, 0078-0777-35 and 0078-0696-35, and the affected NDC numbers for blister packs are 0078-0659-61, 0078-0777-61 and 0078-0696-61.
Finally, for Zofran ODT (ondansetron), the affected NDC numbers for cartons are 0078-0679-19 and 0078-0680-19, and the affected NDC numbers for blister packs are 0078-0679-61 and 0078-0680-61.
For more information, consumers can visit the company’s website.