Revision as of 08:13, 25 May 2012

Anyone that watches television, surfs the web, or flips through magazines and journals is very familiar with advertising for pharmaceuticals picturing attractive, healthy and active people. Prescriptions and over the counter medications are safely used by millions of consumers for various ailments, diseases and medical conditions everyday. While many great things have been accomplished by the development of so many medications and the marketing to millions of consumers, there are also serious side effects or other undesired results. In some cases, the U.S. Food and Drug Administration or manufacturer may recall or withdraw a specific batch or completely remove a medication from the market.

What is a drug recall?

Recalls are, with a few exceptions, voluntary on the part of the manufacturer. However, once the FDA requests a manufacturer recall a product, the pressure to do so is substantial. The negative publicity from not recalling would significantly damage a reputation, and the FDA could take the manufacturer to court where criminal penalties could be imposed. The FDA can also require recalls in certain instances with infant formulas, biological products, and devices that pose a serious health hazard. Manufacturers may of course recall drugs on their own and do so from time to time for any number of reasons.

Recall classifications

There are three drug recall classifications.

Class I

• Reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
• An example would include the diet aid Fen-Phen (fenfluramine/phentermine) which caused irreparable heart valve damage and pulmonary hypertension.

Class II

• Use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
• An example would include a medication that is under-strength but that is not used to treat life-threatening situations.

Class III

• Use of, or exposure to, a violative product that is not likely to cause adverse health consequences.
• Examples might be a container defect (plastic material delaminating or a lid that does not seal), off-taste or incorrect color.

References

1. FDA 101: Product Recalls From First Alert to Effectiveness Checks, http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM143332.pdf
2. Wikipedia, Class I recall, https://en.wikipedia.org/wiki/Class_I_recall
3. Drug Recalls.com, America's Top 10 Recalled Drugs, Augst 2, 2011, http://www.drugrecalls.com/component/content/article/35-drugarticles/166-americas-top-10-recalled-drugs.html
4. Seamon MJ (2011). Active Pharmaceutical Ingredients and the Globalization of Pharmaceutical Manufactures: Contributors to US Drug Recalls and Shortages Pharmacy Law Column / Drug Store News Pharmacy Practice , (August), http://www.cedrugstorenews.com/userapp/August%202011%20Law%20Column.cfm