In 1982, seven people died when an unknown person placed cyanide into bottles of Tylenol in Chicago. Johnson & Johnson responded by recalling every product which contained acetaminophen throughout the U.S. It was the largest nationwide recall of a drug in history and had a lasting impact on how drug recalls were handled.
Today's food and drug recalls are not nearly as dramatic and are handled professionally using the lessons the drug companies and legal professions learned when the Tylenol murders happened. Nevertheless, if you are ever affected by a drug recall, you should know what they mean and what to do if one happens.
What Are Drug Recalls?
The Food and Drug Administration (FDA) and drug manufacturers must cooperate in drug safety. A drug recall occurs when the manufacturer pulls a prescription or over-the-counter (OTC) medication from the market. Drug recalls are voluntary, but the FDA has the authority to order the recall of certain medical devices. FDA drug recalls are not mandatory, but the FDA can bring government regulators into the case.
A drug recall means that the drug can no longer be sold, and the product is removed from all pharmacies, hospitals, and other places where it is administered or sold. A recall notice is provided to the public to destroy or return any unused medication. In addition, if the recall is due to harmful effects or dangerous drug interactions, the notice may advise patients to seek medical care.
Why Are Drugs Recalled?
A pharmaceutical company may recall drugs for several reasons. These can be as simple as mislabeling or improper packaging or as serious as potentially fatal adverse reactions. Some of the most frequent causes of voluntary recall include:
- Poor labeling. If the labeling is misleading or confusing, it can be recalled. If the instructions for dosing are unclear or could lead to improper use of the medication, then the medication will be pulled
- Poor or improper packaging. A mistake in packing can lead to immediate recall. For instance, if the box says the medicine is a pain reliever, but the medicine inside is an antihistamine, it must be recalled.
- Manufacturing error or contamination. If problems during manufacture lead to harmful substances contaminating the medication, or incorrect fillers being used, the drug will be recalled. For instance, certain inert binding agents cannot be used in some medicines even though they are not harmful by themselves.
- Quality control. Sometimes a batch recall may be issued because it does not meet quality control standards. There may be nothing harmful about the product, but it is not up to the company’s requirements.
In cases with more serious issues, the Federal Drug Administration (FDA) will formally request the company to recall all the drugs even if all the other conditions are acceptable.
An “adverse reaction” is an undesirable, unexpected, or dangerous effect caused by medication. An adverse reaction differs from a “side effect” in being more harmful or less controllable. An "allergic reaction" may be an adverse or a side effect, depending on the nature of the reaction. For instance, sneezing may be a side effect, but anaphylaxis would be an adverse reaction.
Side effects are sometimes secondary effects, whereas adverse reactions are effects that were not anticipated by the use of the drug. Adverse reactions will lead to drug recalls.
The FDA may request a manufacturer recall a product when there is a risk of illness, injury, or deception, even if no other adverse reactions have been reported. The FDA may have received complaints from consumers or healthcare providers or conducted proprietary research, even if the manufacturer has not initiated a recall.
The FDA developed a series of guidelines for companies to follow when recalling a drug or medical product (21 CFR 7). This includes a series of classifications to help determine how serious a recall should be and who needs to be notified that it is taking place:
There is a reasonable probability that the product will cause serious injury or death. Recalls have included pacemakers, heart valves, and lifesaving drugs.
Most recalls are Class II recalls. The drug or device will cause temporary or reversible adverse effects. For example, knee and hip implant failures are Class II recalls.
The product is unlikely to cause injury. OTC medications, packaging errors, and container defects are Class III recalls.
If you hear about medical devices or drugs recalled by FDA, don’t panic. Most medication recalls are minor and involve packaging or labeling issues. Here are the steps you should take at the consumer level if you learn of a drug recall.
If the drug is an OTC medication, stop taking it. Return it to where you purchased it, speak to the pharmacist, and request a refund. The pharmacist may need to return the product to the manufacturer, and there is often a store refund policy for drug recalls.
If the drug is a prescription drug, call your doctor immediately. You should never stop taking a drug without speaking to a healthcare professional. Ask your doctor what you need to do. You may need a new prescription or an alternate medication.
If you have purchased a medication of any kind, and notice an unusual smell, appearance, or color in the medication before you take it, don’t use it. Contact the pharmacy right away to see if the medication has been recalled and return the package to the pharmacy. Never use an unlabeled product or unpackaged medication.
Never flush suspect or unused medication down the toilet or throw it away. Return it to the pharmacy for disposal.
When Should You Hire a Lawyer?
If you have used a drug or other defective product that was the subject of a Class I recall, you need the services of a medical malpractice attorney immediately. Drug recall cases are subject to statutes of limitation, and the notice of the recall starts the calendar running.
If you believe you have used a medication that was recalled and you are unsure if there has been a recall, all recalled drugs and devices are listed on the FDA’s website. They have separate listings for food, drugs, medical devices, and other FDA-regulated product.
You should contact a drug recall attorney if a medication or medical device injured you. Your time to file a lawsuit is limited, and gathering the information will take time. Contact Ratzan Weissman & Boldt for a free and confidential review of your case. Our attorneys will let you know the best way to proceed. Contact us today.