Novartis and Sandoz, its generics arm, have initiated a recall of 470,000 blister packages of 12 prescription drugs in the US because certain blister card packages distributed in the US do not meet US child-resistant packaging requirements. A lack of proper packaging could pose a poisoning risk if the medicines therein are swallowed by children, according to the US Consumer Product Safety Commission (CPSC), which posted a notice of the recall.

The company is voluntarily implementing a CPSC-approved corrective action plan for the affected product packages distributed in the US in cooperation with the CPSC and the US Food and Drug Administration. The company notes that this action is not a result of any quality or safety concerns with the medications for their intended use.

The recall was initiated on July 6, 2018 and applies to medicines distributed to clinics and pharmacies nationwide in the US as a prescribed medicine from September 2016 to June 2018. The company has received one report of a child ingesting haloperidol from a blister pack prior to the July 6, 2018 recall, according to the CPSC’s report.

The drugs recalled are for certain lots of the following from Novartis: Zofran ODT (ondansetron hydrochloride) and Entresto (sacubitril/valsartan) and from Sandoz:  azithromycin, donepezil ODT, haloperidol, imipramine, isosorbide dinitrate, naratriptan, ondansetron ODT, ondansetron tablets, perphenazine, and risperidone ODT. The products were manufactured in Croatia, India, Ireland, Israel, Italy, Singapore, Spain, the UK, and US, according to the CPSC.

CPSC is advising consumers to immediately secure the blister cards to keep them out of the sight and reach of children and to contact the companies for further instructions. The companies are advising consumers to continue to use the medication as directed once the blister packages are secured.

Source: US Consumer Product Safety Commission, Novartis, and Sandoz