FDA Warns of Potential Problems with Endo Pharmaceutical Prescription Painkillers

The U.S. Food and Drug Administration (FDA) just issued a warning about a painkiller mix-up. Healthcare professionals and patients are being advised that mix-ups may have occurred with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site.

The issue occurred when these products were packaged and labeled at the site, with tablets from one product type potentially having carried over into the packaging of another product. This mistake could result in a stray pill of one medicine ending up in the bottle of another product, said the FDA, which said the likelihood of this problem occurring in drugs dispensed to patients is estimated to be low.

Endo Pharmaceuticals said they are aware of only three product mix-ups concerning these drugs since 2009; pharmacists discovered all three. Endo said it is not aware of any patient having experienced a confirmed product mix-up, or of any adverse events attributable to a product mix-up. Regardless, the FDA is advising patients and healthcare professionals to examine opiate medicines made by Endo that they may have in their possession to ensure all the tablets are the same. The FDA said that it and Endo are providing instructions on how to identify an incorrect tablet in these medicines and other information, which can be accessed at the FDA’s website at: http://www.fda.gov/Drugs/DrugSafety/ucm286232.htm and http://www.fda.gov/Drugs/DrugSafety/ucm286226.htm.

Opiates are potent medications prescribed to alleviate pain and are available only by prescription. The following Endo products may be affected:

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

Additional information can be accessed at www.endo.com and Endo Pharmaceuticals can be reached, toll-free, at 1.800.462.3636.

The FDA notes that there may be periods of shortages for these products and said it is working with Endo and Novartis to minimize the degree of impact. Product shortage will depend on how quickly safeguards can be put in place to prevent this manufacturing issue from happening in the future and how soon manufacturing can be re-started.

Meanwhile, we just wrote that Novartis Consumer Health, Inc. recalled some of its over-the-counter (OTC) drugs distributed nationwide to wholesalers and retailers, also over potential mix-ups and involving all lots of select bottle packaging configurations of its Excedrin® and NoDoz® products with expiry dates of December 20, 2014 or earlier, as well as Bufferin® and Gas-X Prevention® products with expiry dates of December 20, 2013 or earlier, in the United States. Products may contain stray tablets, capsules, or caplets from other Novartis products, or may contain broken or chipped tablets.

Novartis Consumer Health Inc. said it is advising its distributors and customers of the problem and is arranging for return of all recalled products. Wholesalers and retailers should stop distribution and return the affected product using Novartis Product Return information that is being provided to them. Consumers in possession of the recalled product(s) should stop using the product(s) and contact the Novartis Consumer Relationship Center, toll-free, at 1.888.477.240, Monday through Friday, from 9:00 a.m. to 8:00 p.m. Eastern Time (ET) for information on how to return the recalled OTC drugs and receive a full refund. The firm also suggests consumers visit its website at www.novartisOTC.com.

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