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U.S. Department of Health and Human Services

Drugs

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Certain Opiate Products Made for Endo Pharmaceuticals

FDA is advising patients and healthcare professionals of a potential safety risk associated with certain opiate products manufactured for Endo Pharmaceuticals by Novartis Consumer Health. FDA’s inspection of the Novartis manufacturing facility found a packaging problem that may result in a pill, tablet or caplet getting mixed in with a different prescription. The risk of pills ending up in the wrong bottle is a rare event.

FDA is working with Novartis and Endo to resolve the packaging problem.  Meanwhile, to ensure patient safety and access to needed pain medicines, patients and healthcare professionals should follow the instructions in the links below to identify whether there is a wrong pill in a medication bottle.

All of the pills in the bottle should look the same.  If patients find a pill that is different in shape, size, color, or markings, they should bring their medicine bottle to their pharmacist and not take any of those pills. Patients who have questions should call their pharmacist, healthcare provider, or Endo Pharmaceuticals’ call center at 1-800-462-3636.