Revision as of 07:57, 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, and simple text errors such as the incorrect expiration date on the manufacturer's bottle.

How drug recalls work

When an FDA-regulated product is either defective or potentially harmful, recalling that product, removing it from the market or correcting the problem is the most effective means for protecting the public. This is a multi-step process.

Step 1: Reports of adverse effects

FDA first hears about a problem product in several ways:

• A company discovers a problem and contacts the FDA.
• The FDA inspects a manufacturing facility and determines the potential for a recall.
• The FDA receives reports of health problems through various reporting systems.
• The Centers for Disease Control and Prevention (CDC) contacts the FDA.

After receiving enough reports of adverse effects or misbranding it decides the product is a threat to the public health and it contact the manufacturer to recommend a recall.

Step 2: Manufacturer agrees to recall

Provided the manufacturer agrees to a recall, they must establis a recall strategy with the FDA that addresses the depth of the recall, the extent of the public warnings, and a means for checking the effectiveness of the recall. The depth of the recall is identified by wholesale, retail, or consumer levels.

Step 3: Customers contacted

Once the strategy is finalized the manufacturer contacts it customers (pharmacies, wholesalers, etc.) with the following information:

• the product name, size, lot number, code or serial number, and any other important identifying information,
• reasons for the recall and the hazard involved, and
• instructions on what to do with the, beginning with ceasing distribution.

Step 4: Recall listed publicly

FDA recalls are listed in the FDA's weekly enforcement report ( http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm ), see recent recalls at http://www.fda.gov/Safety/Recalls/default.htm , and you can receive email alerts at https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_48 . Many subscription services, such as Medscape and Drug Facts and Comparisons eAnswers, also include drug recall information.

Step 5: Effectiveness checks

FDA evaluates whether all reasonable efforts have been made to remove or correct a product. A recall is considered complete after all of the company’s corrective actions are reviewed by FDA and deemed appropriate. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned, and investigates why the product was defective in the first place.

10 worst drug recalls in the United States

See also

FDA: Recalls, Market Withdrawals, & Safety Alerts, http://www.fda.gov/Safety/Recalls/default.htm
Food and Drug Administration
MedWatch

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