FDA Lawyer » FDA Attorney » FDA Law Firm » Food Drug Administration Lawyers » Food and Drug Law
FDA Lawyer - FDA Attorney - FDA Law Firm

FDA Shuts the Doors on Novartis Facility For Bad Oxycodone Pharmaceutical Packaging

In a recent release by The American Society of Health-System Pharmacists :

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.


There are no comments yet...

Kick things off by filling out the form below.

Leave a Comment