Novartis and its generic unit Sandoz have announced a US nation-wide recall which affects 12 different drug products packaged in blister packs. The voluntary recall was initiated after the companies learned that certain lots of these drugs were enclosed in blister packs that failed to meet federal standards for child-resistant packaging.
The recall affects an estimated 470,000 packages of pills which were sold at pharmacies across the US between September 2016 and June 2018. Reports that a child was able to open one of the blister packs and ingest the antipsychotic drug haloperidol suggest that this event was the trigger behind the massive recall.
The companies say that while the recall does not apply to the quality or safety of the medications, if children are able to remove and consume the pills from the blister pack, they could be at risk of serious harm. They also say that any drugs manufactured by Novartis and Sandoz which are packaged in bottles are not affected by this recall.
“At Sandoz and Novartis, we take our responsibility for consumer safety very seriously,” said the companies in a statement regarding the voluntary recall. “As soon as we became aware of the issue, we immediately notified the US Consumer Product Safety Commission (CPSC) and Food and Drug Administration (FDA) that the blister packs at issue are not compliant for consumer home use. As a result, we are voluntarily recalling and implementing corrective action for these selected blister packs.”
The recalls apply to medications belonging to a number of drug classes, including antibiotics, antidepressants, and antipsychotics as well as drugs designed to treat Alzheimer’s disease, migraines, heart failure, and nausea and vomiting associated with cancer chemotherapy.
Affected medications manufactured by Sandoz include various doses of azithromycin, donepezil ODT, haloperidol, imipramine, ISDN (isosorbide dinitrate), naratriptan, ondansetron ODT, ondansetron, perphenazine and risperidone ODT. All of these drug products were packaged for at-home use.
Just two medicines manufactured by Novartis are included in the recall – Entresto (sacubitril/valsartan) tablets and Zofran ODT (ondansetron) – however multiple doses of each are affected. While these products were only intended for patient use in a hospital setting, Novartis says that some of the packs were sent to retail pharmacies, therefore the affected drugs could have ended up in patients’ homes.
Patients are encouraged to continue taking their medication as prescribed, however they’re also urged to keep the drugs out of reach of children. They say that patients and pharmacists in possession of affected batches of these drug products should contact Novartis directly for instructions on what to do with the incorrectly-packaged medicines. Patients will be provided with a child-resistant, re-sealable pouch designed to safely store their medications before they need to refill them.