What are FDA Drug Recalls?
The United States Food and Drug Administration is an agency of the Department of Health and Human Services, an executive department of the United States Government. The FDA’s job is to monitor safety of products that have potential to harm you like foods, drugs, and medical devices and toys.
The FDA regulates testing of new drugs, but sometimes the testing does not reveal all the possible side effects. After the drug has been released for sale and a large number of people have taken the drug, harmful side effects can emerge. When the FDA determines a drug is unsafe, it issues a recall, which is either an order or a request to the manufacturer(s) to take the drug off the market.
Important Update About Zantac Drug Lawsuits
April 1, 2020: The U.S. Food and Drug Administration has announced it is now “requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac).” Lawsuits are now being filed for those harmed by Zantac and its generic versions. Please visit our Zantac Lawsuit page to learn how to begin your important case.
What Is a Recall?
According to Federal Regulations, a recall is a voluntary action which, if not complied with could be enforced with a court action. It may begin with a request to the drug company to recall the drug because it violates a law. There are strict requirements for how this discussion takes place, and how it must be documented by the appropriate representatives.
What Are the Different Drug Recall Classes?
There are four kinds of drug recalls, three of which are initiated by the FDA, and one by the manufacturer:
- Class I – This is the most urgent type of recall issued by the FDA and occurs when the FDA orders a manufacturer to take a drug off the market because it is likely to cause serious harm or death;
- Class II – FDA suggests taking the product off the market, because it may cause temporary or reversible health problems or there’s a remote chance of serious health risks;
- Class III – FDA asks for product recall, perhaps for mispackaging, contamination, or similar problem;
- Market Withdrawal – The firm removes a drug from the market due to tampering or some other problem not subject to FDA regulation.
How Is a Drug Recall Implemented?
- Reports of Unsafe Drug – Reports can come from doctors, patients, researchers, manufacturers, distributors, overseas authorities, or any individual, group or organization which would know about a problem.
- Assessment of Danger – In order to develop a strategy for recalling a drug, specifics about the problem have to be evaluated, including whether the initial report is valid. Serious problems which could lead to a Class I or II recall must be reported to the Department of Health within 24 hours of receiving the complaint. There are forms to be completed which have to be sent to specific agencies.
- Recall Strategy Developed – Each recall is different, and a list of information is gathered before developing a strategy, depending on how dangerous the drug is and what level recall will be used (I,II,or III).
Public Warning – Info about all recalls is posted on the FDA website. For some dangerous situations, a press release is issued.
- Monitoring – The FDA monitors recalls to make sure they are implemented in a way that removes the public danger.
- Recall Ended – After the FDA is notified that the recall is complete, the recall will be terminated. Information on the drug that was recalled is available to the public in the FDA archive.
Dangers of Recalled Drugs
Drugs are recalled because of safety issues. If you need to take a drug that has been recalled, whether by the FDA or the manufacturer, you should call your doctor immediately and find out what to do. There may be a safer alternative to the recalled drug you’ve been taking.
When a drug is released to the general public to be sold over the counter or prescribed by your doctor, the manufacturer must list all known side effects so that patients and doctors know of the potential risks. You’ve probably seen one of the TV ads for a drug, where the possible side effects are listed at the end of the commercial. This is the law, and if a pharmaceutical company does not list the known side effects every time they promote or advertise their drug, and also include the warnings within the drug packaging, they are guilty of the federal crime of mislabeling.
One recent case of mislabeling is where the antipsychotic medication Risperdal was recalled by the manufacturer, a subsidiary of Johnson & Johnson, ostensibly because it was found to contain a contaminant from the wood pallets it was placed on. Nationwide lawsuits allege that the manufacturer failed to warn that a possible side effect of taking Risperdal is a hormonal imbalance in adolescent boys and men which causes them to develop breasts. Mislabeling (failing to warn about all possible side effects) is a crime. Johnson & Johnson pled guilty and settled with the United States government for 2.2 billion dollars.
However, Risperdal victims are not entitled to the money Johnson & Johnson paid to the government, and the company has since paid out confidential settlements to victims. But once a company has pled guilty to breaking the law, there’s a good chance that a civil jury will find in favor of the plaintiff, if the plaintiff takes the case to court instead of settling. A Texas jury awarded one Risperdal victim $2.5 million dollars.
Even if the drug company gives a non-medical reason for a drug recall, there could be a hidden reason that the company is not admitting for fear of lawsuits, bad publicity, criminal convictions, and the like. Any kind of recall is a warning sign not to use a product.
Should I Call an FDA Recall Law Firm?
If you have taken a drug that was recalled and you have experienced unusual physical symptoms/side effects you need to speak to a lawyer immediately. Even if the drug was recalled by the company for another reason than for the side effects you’re experiencing since you started taking it, you may have been harmed by the drug. Pharmaceutical companies sometimes want to hide the real reason they are recalling a drug.