Novartis recalls four OTC drugs citing factory malfunction

By Dr. Ananya Mandal, MDJan 9 2012

Swiss pharmaceutical firm Novartis has announced that it is recalling four different products sold over the counter in the United States after receiving reports that there if malfunction at one of its plants.

The affected drugs are Excedrin, NoDoz, Bufferin and Gas-X Prevention, Novartis Consumer Health (NCH) said in a statement. Novartis said it was recalling all lots of bottles containing Excedrin and NoDoz with expiration dates of Dec. 20, 2014, or earlier as well as Bufferin and Gas-X Prevention with throw-out dates of Dec. 20, 2013 or sooner.

In the announcement the company said, “NCH is taking this action as a precautionary measure, because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets…Mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength than intended or receiving an unintended ingredient. This could potentially result in overdose, interaction with other medications a consumer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient.”

The group stressed however that it was not aware of adverse effects among the affected products' consumers. The plant in Lincoln, Nebraska where the products are manufactured was shut down last month and Novartis said improvements and renovations were being carried out there. Novartis said the recall and improvement work at the Lincoln plant will result in a fourth-quarter charge of $120 million before tax. The facility’s products account for less than 2 percent of Novartis Group sales, the company said. The drug maker had sales of $50.6 billion in 2010.

Julie Masow, a spokeswoman for the Basel, Switzerland-based company, said she didn’t immediately have a number for the amount of tablets and gel caps involved in the recall. She said there hadn’t been any reports of overdoses or allergic reactions from the stray material or broken and chipped medication. The Lincoln facility has 620 employees and about 200 temporary workers, Masow said.