- 25
- January
2012
Swiss pharmaceutical Novartis recently recalled 1,645 lots of over-the-counter medications that may be mixed with powerful painkillers such as Percocet, Endocet, Opana and Zydone. These powerful medications were apparently mixed with products like Gas-X, Buffering, NoDoz and Excedrin.
Novarta has said it isn't aware of any confirmed cases of product mix-ups or any cases where patients have been injured, but it isn't out of the woods yet. The pharmaceutical is recalling the over-the-counter products, but not the painkillers, as the possibility of mix-up and the danger of finding a stray pill is low.
Consumers and patients are being advised to examine the product packing to ensure all the tablets are similar in shape, color, size and marking. Any different looking pills should be returned to a pharmacist. Consumers are also told they may contact the company for a refund.
The potential mix-up was discovered during an FDA inspection of the Nebraska facility where the drugs were manufactured. Inspectors found a manufacturing problem that could have allowed pills to become stuck in machinery and carried to packing for other products. That investigation is reportedly still ongoing, so it isn't known whether any penalties will result. Last summer, FDA inspectors cited the plant for a number of quality control problems.
Since 2009, the company has reportedly failed to properly investigate 166 complaints of mixed-up pills found in Novaris bottles.
The Nebraska facility is now being shut down, causing regulators to be concerned about a potential shortage of the painkillers.
Source: CBS News, "FDA: Novartis pill mix-up may involve prescription painkillers," Monica DyBuncio, January 10, 2012.
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