Novartis and Sandoz withdraw medicines from US over packaging concerns

9 July 2018 (Last Updated July 9th, 2018 12:08)

Novartis and its affiliated Sandoz division have voluntarily recalled certain lots of 12 blister packs of medicines from the US market as the packaging did not meet US federal requirements.

Novartis and Sandoz withdraw medicines from US over packaging concerns
Donepezil ODT. Credit: US Consumer Product Safety Commission.

Novartis and its affiliated Sandoz division have voluntarily recalled certain lots of 12 blister packs of medicines from the US market as the packaging did not meet US federal requirements.

Both Novartis Pharmaceuticals and Sandoz noted that the move is not due to concerns with the products, but instead because the blister card packages pose a risk of harm in case the tablets are swallowed by children.

The corrective action plan by Novartis Pharmaceuticals covers select lots of Zofran ODT 4mg and 8mg tablets, and Entresto 24mg/26mg, 49mg/51mg and 97mg/103mg in 100 hospital unit dose blister packages.

A statement from Novartis Pharmaceuticals read: “These blister packs were developed solely for use in institutions. However, we learned that some of these institutional packs were sent to retail pharmacies, indicating that they may have been dispensed for in-home use.”

“These blister packs were developed solely for use in institutions. However, we learned that some of these institutional packs may have been dispensed for in-home use.”

Sandoz is also recalling production lots of count hospital unit dose blister packages of Azithromycin 250mg, Haloperidol 0.5mg, 1mg, 2mg, 5mg and 10mg, Imipramine 25mg and 50mg, ISDN 10mg and 20mg, and Perphenazine 2mg, 4mg and 8mg.

The company has additionally issued corrective action plan for Donepezil ODT 5mg and 10mg, Naratriptan 2.5mg, Ondansetron ODT 4mg and 8mg, Ondansetron  8mg, and Risperidone ODT 0.5mg, 1mg, 2mg, 3mg and 4mg.

Sandoz said: “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 companies have advised consumers and pharmacies who have bought or sold the impacted blister packs to contact them.