Novartis' Troubles With Packaging Continue

Editor's Choice
Main Category: Pharma Industry / Biotech Industry
Also Included In: Pharmacy / Pharmacist;  Pain / Anesthetics
Article Date: 09 Jan 2012 - 12:00 PST

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Novartis Consumer Health announced earlier today a recall on certain OTC medicines that were badly packaged and might have broken or chipped pills, as well as incorrect product mixed into bottles of pills. Rather worrying for consumers with risks of possible wrong or overdoses of their medicine.

Now the problems seem to be more endemic with the FDA inspection of the Novartis' Manufacturing facility finding other drugs that may have become mixed in the packing process.

It's rare for pharmaceutical manufacturers to have a problem of mixing up drugs, as the products are usually pressed into pills on a dedicated machine for that particular batch of the drug. It shouldn't really happen that different medications come anywhere near each other. Nonetheless, there appear to have been some fairly major procedural issues at the Novartis plant.

The products in the spotlight this time are opiate products made for Endo Pharmaceuticals by Novartis Consumer Health. The FDA is working closely with both companies to resolve the problems and prevent them occurring in the future.

The FDA is providing links on its website to help consumers and practitioners identify if there is a wrong pill in their medication. Patients and healthcare professionals would be wise follow the instructions on the links below closely, to identify whether there is a wrong pill in a medication bottle. Whilst the previous issue related to OTC products, these powerful oxymorphone and oxymorphone based painkillers could cause a patient serious issues if wrongly taken.

The problem relates to the following products :

• 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

The most useful link is a visual guide from Endo Pharmaceuticals, showing the types of pills that may have been mixed :

Visual Guide

Additional information is available from the FDA and Endo's website :

http://www.fda.gov/Drugs/DrugSafety/ucm286226.htm

http://www.fda.gov/Drugs/DrugSafety/ucm286232.htm

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Written by Rupert Shepherd


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