The Swiss giant drug manufacturer Novartis AG, in line with the US Federal Drug Administration (FDA) and the South African Medicines Control Council recommendations, is urgently recalling, as Pharmaceutical International
has reported, all supplies of one of its medicines called Excedrin from South Africa.
This is the latest issue for troubled manufacturer. Last week the Digital Journal
reported that Novartis is under investigation by the European Union following the deaths of 11 patients who took the drug Gilenya
Excedrin is a painkiller used by migraine sufferers and it has been on the market as a Novartis product since 2006. It is available over the counter from pharmacists or by prescription and it is marketed in 40 countries worldwide. The drug contains caffeine, aspirin and paracetamol.
The recall in South Africa was announced, according to the South African media outlet the Sowetan
, at the end of January. This followed an investigation in the US has been triggered by the FDA. The FDA recall
was a "Class I, Type A" notice. The FDA describe such recalls as being for: "defective dangerous potentially life-threatening medicines that predictably or probably could result in serious health risk-adverse events or even death."' The FDA recall not only applied to Excedrin, but also to other over-the-counter products: Bufferin, Gas-X Prevention and NoDoz. The full extent of this remains unclear, according to an earlier report in the Boston Hearld
The reason for the recall is because of a risk of a mix-up of different products in the same bottle which could result in consumers taking the incorrect product and receiving a higher or lower strength than intended or receiving an unintended ingredient. The mix-up occurred at Novartis' Lincoln, Nebraska facility.
The press statement
from Novartis states:
"This recall is a precautionary measure following consumer complaints of chipped and broken tablets and inconsistent bottle packaging line clearance practices at our Lincoln, Nebraska facility, which could result in bottles containing foreign tablets, caplets or capsules".
Although the recall is only precautionary, according to Novartis, the regulatory authorities seem sufficiently concerned about the matter and a product recall is a major step. The mistake is likely to cost tens of thousands of dollars.