Bufferin, Excedrin, NoDoz, Gas-X Recalled
Pill Mixup: Bottles May Contain Stray Pills, Prescription Painkillers
FDA: Plant Problems Date to 'at Least 2009'
In a statement, Novartis says it confirmed the problem during an internal product review following customer complaints. According to an FDA inspection report dated June 13 to July 8, 2011, those complaints have been coming in since "since at least 2009."
In the report, FDA inspectors blast plant management for failing to investigate numerous consumer complaints. The inspectors note that Novartis blamed pill mix-ups on "product pilfering" or on events that happened after the pills left the plant. The report says there was no evidence to support these conclusions.
Endo says it has received only three complaints of pill mix-ups. All three were caught by pharmacists before the drugs were given to patients. Endo officials were not mentioned in the June/July 2011 FDA inspection report.
Late last year, Novartis suspended operations at the plant "to accelerate maintenance and other improvement activities at the site," according to a company news release.
It's not yet clear whether there will be shortages of any of the recalled over-the-counter drugs. But Endo says it expects to see shortages of some of its opiate pain medications. Fortunately, the FDA says alternative versions of each medication are still available.
Prescription Pain Drug Mix-Up
The following Endo Pharmaceutical products may have been affected by the packaging problem.
- Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII
- Opana (oxymorphone hydrochloride) CII
- Oxymorphone Hydrochloride Tablets CII
- Percocet (oxycodone hydrochloride and acetaminophen USP) Tablets CII
- Percodan (oxycodone hydrochloride and aspirin, USP) Tablets CII
- Endocet (oxycodone hydrochloride and acetaminophen USP) Tablets CII
- Endodan (oxycodone hydrochloride and aspirin, USP) Tablets CII
- Morphine Sulfate Extended-Release Tablets CII
- Zydone (hydrocodone bitartrate/acetaminophen tablets, USP) CIII
The FDA is asking people who take prescription pain medications to take a closer look at their pills before swallowing them.
"We are asking patients to check their medicines and to look for tablets of a different size, shape, or color from their regular medicine," says Cox. "If they find any tablets that are different from the rest, they should stop taking their pain medicine and take the medicine to their pharmacy."