There are 12 different medications from Novartis and, its generic medicine subsidiary, Sandoz that will be recalled, all of which are packaged as blister packets.
As part of the US Consumer Product Safety Commission (CPSC)’s regulation, prescription drugs are required to be child-resistant by the Poison Prevention Packaging Act.
However, the CPSC revealed there the companies involved had “received one report of a child ingesting haloperidol from a blister pack.”
Haloperidol is an antipsychotic medication that is used in the treatment of schizophrenia, as well as certain neurological disorders, such as Tourette syndromes, and psychosis.
A spokesperson for Novartis informed us that the case had seen the company “review all blister packs in our portfolio, and we discovered that blister packs for other products were not child-resistant, which are now recalled as part of this communication. Many of our blister card packaged medicines were intended for institutional use only and therefore were not intended to be compliant for consumer home use.”
“We learned, however, that some packages were distributed to retail pharmacies and could have been dispensed for household use,” the spokesperson added.
In the meantime, to avoid a shortage of medication across the 12 products and, as a temporary measure, Novartis’ spokesperson said the company would “be offering to provide child-resistant, re-sealable pouches to patients for storage of the blister packs in their homes as an interim measure to continue their current treatment with their medicines. When a patient refills a prescription of most of the medications, the medication will be dispensed in compliant child-resistant packaging.”
The spokesperson noted that there are no safety issues regarding the medication, only the packaging is faulty.
The latest hiccup for the Sandoz unit comes amid speculation that Novartis will look to shed the US operations of the generics producer. The potential move comes as pricing pressure makes the generics market particularly difficult in the US, amid a concerted effort by the US Food and Drug Administration to drive down prices of generic medicine.