As a consumer, it is important to be aware of devices or drugs that may affect your health. In 2016 alone, manufacturers recalled 4,448 drug and device products, according to the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research. Of those recalls, the FDA classified 219 as Class I. Class I recalled products have the potential to cause serious harm or death.
“Major drug recall history suggests that lots of carelessness is involved during the drug development and manufacturing period,” doctors Upendra Nagaich and Divya Sadhna wrote in a study published in 2015 in the International Journal of Pharmaceutical Investigation. “The long list of drug recalls on FDA website is evidence that still industries are not following the standard guidelines issued by FDA.”
What Is a Recall?
When a drug or device is either defective or potentially harmful, recalling that product is considered the most effective way to protect the public. The FDA defines a recall as “a method of removing or correcting products that are in violation of laws administered by the U.S. Food and Drug Administration.”
Reasons for a recall can range from issues with the packaging to reports of life-threatening and even fatal injuries. For consumers, a recall may mean something as minor as returning a damaged pill bottle to a pharmacist or as major as undergoing surgery to remove a defective implant.
FDA-regulated products subject to recall include:
- Medical devices
- Blood and blood products
- Radiation-emitting products
- Transplantable human tissue
Who Can Initiate a Recall?
Contrary to what most people may think, the FDA can’t recall a drug nor can it force a company to do it. The agency can only recommend a drug recall. The manufacturer must initiate it.
The FDA can sue a company that does not follow its recommendations, but because of lack of resources, this rarely happens. As a result, drugs linked to serious side effects and injuries may remain on the market for years.
Although the FDA can order manufacturers to recall medical devices, the agency cannot force a company to recall defective or potentially harmful drugs.
With the current system, critics say it is too easy for manufacturers to put profits before people. In February 2017, U.S. Rep. Rosa DeLauro (D-CT) proposed a new bill called the Recall Unsafe Drugs Act, which would grant the FDA the ability to issue a mandatory recall on a drug.
Although the FDA cannot currently force a mandatory recall of drugs, it can order a manufacturer to recall a medical device by statute if it finds there is reasonable probability that a device may cause serious injuries or death.
The FDA may also compel a mandatory recall if it finds a product made of human cells or tissue poses a serious risk of infection to humans or does not protect against communicable diseases. Vaccines and blood products fall into this category.
How Does a Recall Work?
Oftentimes, a company recalls a product only after the FDA raises concerns. The FDA may learn about a problem product by inspecting a manufacturing facility, receiving reports of health problems or hearing about it from the Centers for Disease Control and Prevention (CDC). Sometimes, a company discovers a problem on its own and contacts the FDA. But, before the FDA can recommend or conduct a recall, it must review the drug or device. There are several criteria and steps in the recall process.
Health Hazard Evaluation
When the FDA identifies a product for possible recall — usually, through adverse event reports — it will conduct a health hazard evaluation. The agency assembles a special committee of scientists to review the drug or device.
The committee takes into account the following factors:
- Diseases or injuries that may have already been caused by the product
- Existing conditions that could be a contributing factor (documented with scientific evidence)
- The level of hazard to special segments of the population, such as children or the elderly, and those who could be at greatest risk
- The seriousness of the health hazard and level of risk to exposed populations
- Consequences of long-term or immediate health hazards
The FDA classifies each recall based on the severity of injury that the product may cause. In addition, manufacturers may conduct market withdrawals or medical devices safety alerts.
- Class I recall — This is the most serious type of recall. There is a reasonable probability that the product will cause serious adverse events or death. Products such as pacemakers, heart devices and lifesaving drugs fall into this category.
- Class II recall — The majority of recalls fall in this category. Products under a Class II recall can cause temporary or reversible adverse events. Many medical implants, such as hips or knees, fall in this category. Injuries from Class II devices can still be serious, though are not typically life-threatening.
- Class III — These products are not as likely to cause injuries.
- Market withdrawal — Products withdrawn from the market have minor violations. The manufacturer will pull the product from the market or correct the violation. These products don’t typically show evidence of manufacturing problems.
- Medical device safety alert — Manufacturers or the FDA — usually both — will issue an alert when a medical device may cause risk of serious harm. Sometimes, these are also recalls.
FDA Requested Recalls
For some products, the FDA may request a manufacturer initiate a recall after it determines the products pose risks of illness, injury or consumer deception. This typically happens when a manufacturer has not already taken action to initiate a recall of a possibly dangerous product.
The FDA will notify the manufacturer by phone or in person of the intent to request a recall. It will also send a letter notifying the company that they must immediately recall a product. A formal letter provides the manufacturer with all the information the FDA garnered from its health hazard evaluation and recall classification.
After the FDA classifies a recall, it works with the manufacturer of the recalled device or drug to develop a recall strategy. The strategy takes into account all the information learned from the FDA committee. It addresses the depth of the recall, public warning and effectiveness checks.
Depth of Recall & Effectiveness Checks
The recall strategy will specify the level in the distribution chain to which the recall applies. In other words, it will indicate whether the recall is at the consumer or user level, the retail level or the wholesale level. The manufacturer and the FDA determine the depth of recall based on the degree of hazard the product poses and the extent to which it’s been distributed.
The manufacturer is typically responsible for conducting effectiveness checks to verify that the right people have been notified about the recall and that they have taken appropriate action. These checks are usually conducted throughout the recall until 100 percent of the people specified in the recall strategy have been notified.
The recall strategy will also indicate whether a public warning is needed. The FDA and the manufacturer may issue a warning using the general news media or specialized news media, depending on the audience.
The manufacturer works with the FDA to conduct the recall, but the manufacturer is responsible for notifying its customers, such as doctors and hospitals. Recall communications should be brief and should identify the product and the reason for the recall.
Other information included in recall notifications include:
- The recall classification
- Possible health hazards posed by the product
- Number of products being recalled
- The lot numbers or other identification numbers
- Instructions on how to contact the manufacturer
- Instructions for returning recalled products to the manufacturer
The FDA also announces the recall, withdrawal or safety alert on its website. A weekly FDA Enforcement Report includes all new recalls and their classifications.
Status Reports and Recall Termination
The FDA requests manufacturers submit periodic recall status reports, so the appropriate FDA district office can assess the progress of the recalls. In many cases, a manufacturer must submit a report every two to four weeks, but the frequency may vary depending on the urgency of the recall. These reports continue until the FDA terminates the recall.
Using these status reports, the FDA will evaluate whether “all reasonable efforts have been made to remove or correct a product.” The agency will terminate a recall after it reviews the manufacturer’s actions and determines they meet the criteria laid out in the recall strategy. Sometimes the problem cannot be corrected, but in other cases, a manufacturer will return the drug or device back to the market.
Recalled Drugs and Devices
FDA approval or clearance does not mean a drug or device is safe. Each year, the number of medical devices and drugs on the market increases, and so do the recalls and safety alerts. Sadly, some products are recalled for serious side effects or manufacturing defects that caused injury. Manufacturers may spend millions on a product recall or lawsuits filed against them because of recalled products. The most expensive drug recall to date occurred when Johnson & Johnson recalled 31 million bottles of Tylenol tainted with cyanide. It cost the company $100 million.
Other notable drug and device recalls include:
|Drug or Device||Use||Recall Date||Reason for Recall||Years on Market|
|DePuy ASR Hip Implant||Hip implant||2010||Early failure rate, metal ions in blood, device design||5 years (2005-2010)|
|Ethicon Gynecare Morecellex||Surgical tool for hysterectomy, myomectomy||2014||Increased risk of spreading uterine cancer||10 years (2006 to 2014)|
|Kugel Hernia Patch||Mesh for hernia repair||2005||Bowel perforation, fistula||9 years (1996 to 2005)|
|Yaz||Birth control||2009||Specifications for dosage of drospirenone||2006-Present|
|Eliquis||Atrial fibrillation, to reduce the risk of stroke and blood clots||2017||Tablet Mix-Up||2012-Present|
Emily Miller holds five Health Literacy certificates from the Centers for Disease Control and Prevention as well as a Bachelor of Science in Journalism from the University of Florida. She is a member of The Alliance of Professional Health Advocates, the American Association for the Advancement of Science and the Society for Technical Communication. Emily was diagnosed with a chronic illness as a child and has firsthand experience with many of the topics she writes about as a member of the Drugwatch team. She is an award-winning journalist who has reported on health and legal news for reputable organizations, including the South Florida Sun Sentinel, San Antonio Express-News, UF Health News and Reporters Committee for Freedom of the Press. She draws on her background as both a patient and a journalist to help readers understand complex health and legal topics.