Pharmaceutical company Sandoz Inc. and its affiliate Novartis Pharmaceuticals have recalled twelve medicines from store shelves due to issues with the packaging. The childproof packaging poses a risk because children may actually be able to open it. If you have any young children in the house or visiting, it is important to be aware of which medications are a part of the recall.
In a statement issued on Friday, the companies said that the recall was necessary due to the affected medicines’ blister packaging and its failure to meet US federal requirements for child resistance. The companies further clarify that the recall does not in any way involve the quality or the safety of the medicines themselves. Patients who have been prescribed the medications may continue to take them.
The statement also clarifies that the medications that are packaged in bottles are not affected by the recall.
The drugs affected by the recall include risperidone ODT, donepezil ODT, naratriptan, ondansetron ODT, ondansetron tablets, and Zofran ODT (ondansetron) in blister card packages. Also included are azithromycin, haloperidol, imipramine, ISDN (isosorbide dinitrate), perphenazine and Entresto (sacubitril/valsartan) in hospital unit dose blister packaging.
These have all been sold in pharmacies and clinics nationwide from September 2016 to June 2018 according to the US Consumer Product Safety Commission.
If you have purchased the affected products, the companies advise that you secure them and keep them away from children.
There has already been an incident in which a child ingested haloperidol from a blister pack, according to the CPSC.
For further information, the companies have provided the National Drug Code Number for the affected medicines cartons. They are as follows:
- Affected National Drug Code number for cartons is 0781-5776-69,
- Affected NDC number for blister packs is 0781-5776-06.
- Donepezil ODT
- Affected NDC numbers on cartons are 0781-5276-64 and 0781-5277-64,
- Affected NDC numbers for blister packs are 0781-5276-06 and 0781-5277-06.
- Affected NDC numbers are 0781-1391-13, 0781-1392-13, 0781-1393-13, 0781-1396-13 and 0781-1397-13.
- Affected NDC numbers are 0781-1764-13 and 0781-1766-13.
- ISDN (Isosorbide dinitrate)
- Affected NDC numbers are 0781-1556-13 and 0781-1695-13.
- Affected NDC number for cartons is 0781-5527-37,
- Affected NDC number for blister packs is 0781-5527-06.
- Ondansetron ODT,
- Affected NDC numbers for cartons are 0781-5238-64, 0781-5239-80 and 0781-5239-64,
- Affected NDC numbers for blister packs are 0781-5238-06 and 0781-5239-06.
- Affected NDC number is 0781-1681-33.
- Affected NDC numbers are 0781-1046-13, 0781-1047-13 and 0781-1048-13.
- Risperidone ODT
- Affected NDC numbers for cartons are 0781-5310-08, 0781-5311-08, 0781-5312-08, 0781-5313-08 and 0781-5314-08,
- Affected NDC numbers for blister packs are 0781-5310-06, 0781-5311-06, 0781-5312-06, 0781-5313-06 and 0781-5314-06.
- Entresto (sacubitril/valsartan) tablets
- Affected NDC numbers for cartons are 0078-0659-35, 0078-0777-35 and 0078-0696-35,
- Affected NDC numbers for blister packs are 0078-0659-61, 0078-0777-61 and 0078-0696-61.
- Zofran ODT (ondansetron),
- Affected NDC numbers for cartons are 0078-0679-19 and 0078-0680-19,
- Affected NDC numbers for blister packs are 0078-0679-61 and 0078-0680-61.
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