Drug Recalls

From Pharmacy Drug Guide

A drug recall occurs when a problem is discovered with a medication, and it is removed from the market. Recalls can be voluntary or under order by the U. S. Food and Drug Administration, the FDA. A recall may be announced as a protective action when a drug causes injury to patients or as a precautionary action when a problem is detected which is not expected to be harmful.^[1] The number of drug recalls has increased in recent years, driven both by problems in production and by increased FDA scrutiny.^[2] Both prescription and over-the-counter (OTC) drugs may be subject to recall.

Some recalled drugs have caused deaths or injuries. One of the most well-known recalls is the 1982 recall of Tylenol. Seven people in the Chicago area, including three in one household, died after taking Tylenol capsules that were laced with cyanide.^[3] However, most drug recalls are due to more benign defects.

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U.S. Regulation	FDA
FDA Division of Drug Information	(888)463-6332
Updated information	Available from pharmaceutical company and FDA websites
Causes	Include bottling errors, dosage mistakes, mislabeling
Disclaimer	The information provided by PharmacyDrugGuide.com is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician.

About Drug Recalls

Drugs may be recalled in three ways. First, the manufacturer may voluntarily initiate a recall after discovering a potential problem. Then, if the manufacturer does not order a recall, the FDA may request that they voluntarily do so. Finally, if necessary, the FDA has the statutory authority to order a recall.^[1] The FDA has jurisdiction over the following types of medical products:

• drugs
• vaccines
• medical devices
• other biologics
• blood and plasma products
• veterinary products^[4]

There are several types of recalls or market withdrawals. They are:

• Class I recall: This happens when there is a reasonable probability that a drug will cause serious injury or death.
• Class II recall: This recall is for drugs that may cause temporary or reversible injury.
• Class III recall: Drugs in this class are not expected to cause injury.
• Market withdrawal: This is a minor violation that would not be subject to FDA legal action. Problems that are not caused during manufacturing may be in this category.
• Medical device safety alert: This alert is issued when a medical device is expected to cause substantial harm. It may also be considered a recall.^[5]

The government has a searchable database of recalls on the website Recalls.gov. The site also has a section for recent recalls.

Largest Recalls

Thalidomide: In the late 1950s and early 1960s, thalidomide was prescribed to pregnant women to control morning sickness. It was removed from the market when it was shown to cause limb defects in infants.^[6]

Fen-Phen: Fenfluramine and phentermine were approved for single use for short-term obesity control. The two drugs were often prescribed off-label in combination for long-term use. This resulted in at least 82 cases of cardiac valvular disease. Sixteen of those patients required heart valve surgery, and at least one died. Fenfluramine and phentermine were removed from the market on September 15, 1997.^{[7] [8]}

Vioxx: On September 30, 2004, after five years on the market, Merck voluntarily withdrew Vioxx (rofecoxib) due to increased risk of myocardial infarction (MI) and stroke. In 2003, worldwide sales of Vioxx had totaled $2.5 billion and it was used by 80 million people. In 2007, Merck paid $4.85 billion to settle lawsuits in the US.^{[9] [10] [11] [12]}

Trasylol: Trasylol (aprotinin) was approved in 1993 to reduce blood loss in patients undergoing cardiac surgery. On November 5, 2007, Bayer withdrew Trasylol from the market after a study showed increased risk of kidney damage and deaths from the use of Trasylol. It is estimated that thousands of patients may have died following surgery and the use of Trasylol. The study that showed increased risk was itself halted following increased deaths.^{[13] [14]}

Drug Side Effects

Recent Recalls

Tylenol: On February 17, 2012, seven lots [Tylenol Oral Suspension] were taken off the shelves after manufacturer McNeill Consumer Healthcare voluntarily recalled them. There was no issue with the medicine itself, but faulty packaging made the syrup difficult to dispense. This was the latest in a string of Tylenol recalls, many of them for unpleasant odors. No harmful reactions have been reported in any Tylenol recall since 1982.

Enfamil: On December 22, 2011, retailers began pulling Enfamil Newborn formula from their shelves as a precautionary measure after a 10-day-old infant died from a bacterial infection after consuming the formula. However, a series of two tests on numerous samples revealed that the Enfamil products were safe.^{[15] [16]}

Motrin IB: On December 21, 2011, recalled 59 lots of Motrin IB due to concerns that as the products approached their expiration date, the tablets and caplets might not dissolve as quickly as intended and consumers may have a delay in experiencing relief.^[17]

Virility Max: On November 10, 2011, Keime Incorporated announced a voluntary recall of one lot of a dietary supplement known as Virility Max. An FDA analysis showed that the product contained sulfoaildenafil, an analog of sildenafil, which was not listed on the product label.^[18]

Also See: Johnson and Johnson Recall, Enfamil Recall, Tylenol Recall, Motrin Recall, Benadryl Recall, Lipitor Recall, Miralax Recall, Mylotarg Recall, Depuy Hip Implant Recall, Birth Control Recall

References

1. ↑ ^{1.0 1.1} http://www.fda.gov/drugs/drugsafety/DrugRecalls/default.htm
2. ↑ http://money.cnn.com/2010/08/16/news/companies/drug_recall_surge/index.htm
3. ↑ http://www.usatoday.com/news/health/2007-09-29-tylenol-poisonings_N.htm
4. ↑ http://www.recalls.gov/medicine.html
5. ↑ http://www.fda.gov/Safety/Recalls/ucm165546.htm
6. ↑ http://www.slate.com/articles/double_x/doublex/2011/01/thalidomides_comeback.single.html
7. ↑ http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm179871.htm
8. ↑ http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm180082.htm
9. ↑ http://www.merck.com/newsroom/vioxx/pdf/vioxx_press_release_final.pdf
10. ↑ http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106290.htm
11. ↑ http://www.ccjm.org/content/71/12/933.full.pdf+html
12. ↑ http://www.theage.com.au/national/drug-unfit-for-sale-says-judge-in-compo-case-20100305-powh.html
13. ↑ http://www.trasylol.com/Trasylol_11_05_07_DHCP.pdf
14. ↑ http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/ucm122315.pdf
15. ↑ http://www.enfamilalerts.com/
16. ↑ http://news.businessweek.com/article.asp?documentKey=1376-LWM1DO6S972J01-7JV1MQT6ELVI4AU0E6J1T0NP6V
17. ↑ http://www.fda.gov/Safety/Recalls/ucm284942.htm
18. ↑ http://www.fda.gov/Safety/Recalls/ucm279659.htm