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Carol Eustice

FDA Warns About Packaging Problem Involving Opioid Pain Medications; Recalls OTC Drugs

By , About.com Guide   January 9, 2012

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The FDA (U.S. Food and Drug Administration) is advising healthcare professionals and patients of a potential problem with opioid pain medications manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site. The potential problem is related to the packaging and labeling of the products, likely related to improper clearing of packaging machinery. Tablets of one type of opioid drug may have carried over into packaging of another type. While it is possible that a stray pill may have ended up in the wrong bottle, the FDA claims that the likelihood of this being encountered by a patient or affecting a patient is low. The FDA is advising patients to inspect their opioid prescriptions for color, size, imprint, and shape. If you find the wrong pill mixed in, return the prescription to your pharmacy. Here is a visual guide of the affected pills which include:

  • 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

Novartis has issued a recall for over-the-counter drugs manufactured at the same plant out of an abundance of caution. Novartis Consumer Health, Inc. announced that it is voluntarily recalling all lots of select bottle packaging configurations of Excedrin® and NoDoz® products with expiration dates of December 20, 2014 or earlier as well as Bufferin® and Gas-X Prevention® products with expiration dates of December 20, 2013 or earlier, in the United States. This is a complete list of the recalled products. The products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.

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