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FDA shuts down Novartis facility because of packaging problems


The American Society of Health-System Pharmacists issued the following news release:


A shutdown of the Novartis facility that manufactures Endo oral pain medications was announced today by both Endo and the Food and Drug Administration (FDA). The action was prompted by rare reports that one or more doses of the wrong medication were found in bottles or unit-dose packages, as well as packaging problem noted by FDA during a mid-December inspection. Affected products include oxymorphone, oxycodone with acetaminophen or aspirin, morphine extended release and hydrocodone with acetaminophen.


A recall was not initiated based on the high potential for serious shortages with disruption in care and the low risk of receiving mixed-up products. Endo has warned that short-term supply disruptions may occur. FDA issued a public health advisory this morning that includes guidance for patients and the healthcare community.


More information, a complete list of affected products and FDA's safety instructions for patients, healthcare providers and dispensing pharmacists are available at www.fda.gov/Drugs/DrugSafety/ucm286225.htm. Endo has posted its "Dear Healthcare Provider/Patient/Pharmacist" letters and a visual chart of the affected products to assist with identification at www.endo.com/Supply_disruption.aspx.


TNS JF78JF-120110-3736893 EditorFurigay


(c) 2012 Targeted News Service


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