Safety Alerts & Recalls

What does this mean?

The likelihood of finding a wrong tablet in an opioid pain medication dispensed to you is low and you should not be overly alarmed. For medications already in homes, there are simple steps that you can take to identify whether they have any affected products.

If you take Opana ER, Opana, Oxymorphone, Percocet, Percodan, Endocet, Endodan, Morphine, or Zydone products from Endo Pharmaceuticals, you can follow the steps below to determine if there is a wrong pill in your medication bottle.

1) Carefully look at the tablets in your medicine bottle to make sure they all look the same.

2) If all the tablets in your bottle look exactly the same, you should continue to take your medication as directed by your health care professional.

3) If you discover that any of the tablets in your bottle are a different color or shape from the others, you should promptly take the medicine back to your pharmacy so the pharmacist can review the contents. Your pharmacist will be able to assist you.

4) Please contact Endo Customer Service at 1-800-462-3636 if you have any additional questions or concerns.

If you are not sure who made your prescription pain medicine, but are concerned that the tablets look different than what you expect them to look like, you should talk to your pharmacist.

Patients who have questions should call their pharmacist, healthcare provider, or Endo Pharmaceuticals’ call center at 1-800-462-3636. Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Possible Supply Shortage and Rare Tablet Mix-up For Opioid Pain Medications from Endo Pharmaceuticals

The U.S. Food and Drug Administration (FDA) and Endo Pharmaceuticals are advising patients and healthcare professionals of a potential safety risk associated with opioid pain medicines manufactured for Endo Pharmaceuticals by Novartis Consumer Health. The 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 bottle of another product. The likelihood of this occurring in medication dispensed to patients is estimated to be low. Endo Pharmaceuticals reports that they are aware of only three product mix-ups with respect to these products since 2009.

At this time, no products are being recalled, however, to ensure patient safety and continued access to needed pain medicines, patients and healthcare professionals are being asked to examine the tablets in their prescriptions to identify whether there is a wrong pill in a medication bottle.

The FDA is working with Novartis and Endo to resolve the packaging problem. Production of certain Endo products has been temporarily stopped in order to implement manufacturing process improvements. As a result, Endo expects that there may be a short-term shortage in the supply of these products to patients.

Opioids 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 Tablet

- Opana (oxymorphone hydrochloride) Tablet

- Oxymorphone hydrochloride Tablet

- Percocet (oxycodone hydrochloride and acetaminophen USP) Tablet

- Percodan (oxycodone hydrochloride and aspirin, USP) Tablet

- Endocet (oxycodone hydrochloride and acetaminophen USP) Tablet

- Endodan (oxycodone hydrochloride and aspirin, USP) Tablet

- Morphine Sulfate Extended-Release Tablet

- Zydone(hydrocodone bitartrate/acetaminophen tablets, USP)

To view a visual guide to verify the appearance of these products, please visit: more information here

This public health advisory applies only to tablets manufactured for Endo Pharmaceuticals by Novartis Consumer Health. Liquid and powder form medicines, and blister packaged products manufactured for Endo Pharmaceuticals by Novartis Consumer Health are not included in this alert.

Also several of these products are manufactured by other companies under other brand or generic names; products from other companies are not affected by this alert.

For more information, please visit: more information here

more information here

Source: FDA
Publication Date: 2012-01-09
Last Updated: 2012-01-12
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