The recall of dangerous drugs has become a common occurrence in the recent past. There are many reasons for a drug or dietary supplement recall to be enacted. When an FDA approved drug or supplement is taken in the correct and prescribed dosage and poses health risks, including serious medical reactions and death, a recall may be established. In the event of a pharmaceutical recall the item will be removed from the market to protect consumers.
The Food and Drug Administration (FDA) is in charge of keeping the public safe from dangerous and harmful pharmaceuticals, medical aids, and food and drinks, as well as other consumer items. The pharmaceutical companies are held liable for any medical issues or deaths associated with the use of their products.
Each year there are over 2 million people who suffer from the adverse side effects of drugs and dietary supplements. The NY pharmaceutical litigation lawyers at Wingate, Russotti, Shapiro & Halperin, LLP represent cases involving many different pharmaceuticals and dietary supplements. If you or someone you know has been harmed by a recalled drug, call us today at (212) 986-7353.
New drugs are being introduced all the time, and recalls are all-too-common. This makes it difficult to keep track of what is available and what has been pulled from the market, though the FDA provides comprehensive information on recalls and drug approval. If you believe you have used a pharmaceutical product that may have been recalled, speak with one of our knowledgeable attorneys to find out what you can do.
Recently recalled drugs and supplements include:
- Man of Steel 1 and Man of Steel 2
- Rugby - Diocto Liquid and Syrup
- Super Panther 7K Dietary Supplement
- Andropharm - Sten Z and M1 Alpha capsules
- Bristol-Myers Squibb - Eliquis (apixaban) 5 mg Tablets
- Alvogen - Clindamycin Injection USP
- GEC Laxoplex Dietary Supplement
- Mylan - EpiPen and EpiPen Jr Auto-Injectors
- Edex - Alprostadil for Injection
If you have taken any of the drugs listed above or have encountered adverse reactions due to any other pharmaceutical, dietary supplement, or medical device contact an experienced dangerous pharmaceutical attorney at Wingate, Russotti, Shapiro & Halperin, LLP.
There are quite a few different reasons why a drug would be recalled by a manufacturer or the FDA, depending on the situation. In general, however, the reasons usually come down to a drug being released without approval, a manufacturing flaw, or lack of proper sterility. Sometimes a recall may be required due to additional research or case studies of a drug revealing dangerous side effects or other issues missed prior to launch.
Common causes include:
- Lack of sterility: Cleanliness is very important in the manufacture and bottling of drugs and supplements. There are many guidelines and protocols manufacturers have to follow to be sure their products reach customers with proper sterility. When a violation occurs, or there seems to be a lack of quality assurance, a recall may be necessary.
- Presence of certain items: This type of recall often comes down to something being present in a drug or packaging that is not properly labeled. For example, if an item is labeled as being "Latex Free" but is found to contain latex, then a recall might be ordered. Certain chemicals, such as the presence of steroids, can also require a recall if the supplement or drug is not labeled accurately.
- Particulate matter: Particulate matter refers to very small amounts of unexpected items being found in a product. For example, if human hair or something similar was found in bottles of a drug, then a recall could be needed. The introduction of particulate matter usually happens in manufacturing and bottling, rather than as an intentional component of the drug or its packaging.
- Unapproved new drug: Sometimes a drug or supplement will be released as one product, but is found to contain a new or different drug in addition to what is advertised. If a supplement also has some type of pharmaceutical in it, beyond what was approved or allowed, then it might be recalled. Otherwise, potentially dangerous drug interactions and side effects could occur without the public understanding the risks and dangers.
A drug recall usually begins with a report or complaint filed with the FDA by the public, often after finding something unexpected in a drug container. Recalls can also happen due to testing or publishing of research showing unexpected issues with different pharmaceuticals. The FDA can then act to ensure a recall happens, though sometimes manufacturers can order a recall without any action taken by the FDA. Public statements are often issued, while pharmacies and resellers are notified to remove recalled products from shelves. Customers can typically receive refunds for any recalled items returned to a store.
There are three main types of recalls that can occur, depending on who is responsible for initiating it.
- Firm-Initiated Recalls: A firm-initiated recall happens when the manufacturer of a drug or supplement takes action to recall a product independently of the FDA. The FDA might still assist or help oversee the recall, lending aid as needed or ensuring it is carried out properly. In general, however, this type of recall occurs without government intervention and happens at the order of the manufacturer.
- FDA-Requested Recalls: Sometimes it is necessary for the FDA to step in and request that a business order a recall on a particular item. This is usually done with cooperation from the manufacturer and there is a great deal of communication between the company and the FDA. This type of recall usually happens when there is an apparent danger to the public due to the product.
- FDA-Ordered Recalls: In more extreme cases, the FDA can order a manufacturer to begin the recall of an item. When the order is issued, there is typically a set timeframe in which the recall must happen and procedures regarding how it must be carried out. These are mandatory recalls that a manufacturer must follow to avoid fines or additional legal actions.
If you or a loved one has suffered as the result of pharmaceuticals or dietary supplements contact the attorneys at Wingate, Russotti, Shapiro & Halperin, LLP. Call us today at (212) 986-7353 and we can discuss your options and talk about how to move forward.