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FDA warns of opiate drug mix up for products packaged by Novartis
Jan 9, 2012 3:15 PM

The Food and Drug Administration is warning healthcare professionals and patients that opiate products, including Percocet, manufactured and packaged by Novartis Consumer Health for Endo Pharmaceuticals, may have been mixed up and therefore labeled as the wrong drug.

The affected opiate drugs were packaged at the Lincoln, Neb., Novartis plant, which was also involved in a recall today of over-the-counter products manufactured by Novartis, including Excedrin and NoDoz, because the products may contain either broken or chipped tablets, or stray tablets, capsules, or caplets from other Novartis products.

The warning involves eight other opiates in addition to Percocet. Tablets from one product type may have carried over into packaging of another product. However, the likelihood of this occurring in medication dispensed to patients is estimated to be low. Regardless, the FDA and Endo have instructions on how to identify an incorrect tablet in one of the affected medicines.

Opiates are potent medications used to alleviate pain and are available only by prescription. The following Endo Pharmaceutical products may be 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

Patients should look carefully at all of the pills in their pain medicine bottle. For any questions call Endo Pharmaceuticals at 800-462-3636, or ask a pharmacist or doctor for additional help in identifying whether there are any problems with a medication.

Previously announced today: Recall: Excedrin, NoDoz, Bufferin, and Gas-X Prevention due to broken or stray tablets

FDA Public Health Advisory on Certain Opiate Products Made for Endo Pharmaceuticals [FDA]

—Maggie Shader

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