Novartis is recalling several over-the-counter products such as Gas-X, Excedrin, NoDoz, and Bufferin due to inconsistent bottling, as well as broken gel caps and chipped pills.
“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,” Novartis stated. “This could potentially result in overdose, interaction with other medications a consumer may be taking or an allergic reaction.”
The recall began the day after the FDA released a 13-page Form 483, which cited Novartis’ repeated failures to follow up on quality concerns voiced by patients. The company also failed to inform the FDA of these complaints. Issues raised in the 483 were identified in the summers of 2010 and 2011.
In addition to recalling its products, Novartis temporarily shut down its Lincoln, Neb., plant to fix and improve its manufacturing activities, expecting a $120 million one-time charge.
A full list of products and recall dates can be found at www.novartisOTC.com.