When removing a drug from the marketplace, the first step is typically a recall. In order to most effectively protect the public, recalling a potentially harmful or defective product is done. This is a voluntary action undertaken by a company to completely withdraw a defective medication from the market.
Voluntary recalls are usually initiated by manufacturers after receiving a request from the Food and Drug Administration (FDA) and are done with the agency’s cooperation. Generally, this action is the result of complaints or data surfacing that warrants removing the drug from public use. Manufacturers then halt the distribution of the medication altogether. If manufacturers do not heed the FDA’s recommendation to recall the medication, a mandatory recall can be issued by the government. This is not an action the FDA takes very often, but the potential is certainly a powerful incentive for manufacturers to proactively proceed with the recall process.
What Causes Drugs to be Recalled?
Certain factors are among the most common reasons that any drug is recalled. These include:
- Health Hazard – Some risks are not realized until the medication is in wide use publicly.
- Mislabeling or Poor Packaging – Some medications are recalled because dosing instructions are confusing, or a dosing tool given with the drug has a flaw.
- Potential Contamination – Medication can get contaminated with a substance that is either harmful or non-harmful while in the production or distribution process.
- Wrong Product – An error could occur where medication is packaged in the wrong box.
- Poor Manufacturing – Defective manufacturing can adversely affect a drug’s purity, quality, and potency, leading to a recall.
Popular Medications That Have Been Recalled
Any time a well-known medication gets recalled, the action tends to send shockwaves through the public sphere. After all, doctors who are prescribing medications are supposed to know best for what patients need. In general, this may be true and would help to explain why drugs being pulled from the marketplace make such big news. Previous medication recalls worth noting include:
Zantac – The FDA issued a request to manufacturers in April of 2020 to immediately pull all over-the-counter and prescription ranitidine medications from the market. Zantac is among the drugs that have been found to contain a contaminant, N-Nitrosodimethylamine. During sample testing, the FDA itself did not see unacceptable levels but recognized that impurity increases over time as the medication is stored in hotter temperatures. Due to the recall, no products containing ranitidine will be available in the U.S. for over the counter or prescription use.
Belviq – The medication lorcaserin, also known as Belviq and Belviq XR, has been prescribed for weight loss since its approval by the FDA in 2012. However, the drug was voluntarily withdrawn from the marketplace in the United States in February 2020 after a request was issued by the FDA.
When lorcaserin was first approved, the agency required that a clinical trial be performed to evaluate any cardiovascular risks. Upon completion of the trial, it was determined that the drug could increase the risk of cancer. In fact, emerging data showed increased cancer occurrences five years after patients began using the medication.
Valsartan – This drug is prescribed as a treatment for high blood pressure as well as heart failure. Several medications containing valsartan have been recalled in the United States because of an impurity linked to cancer. The same contaminant found in Zantac, NDMA, is responsible. This probable carcinogen has been found in drugs made by Solco Healthcare, Major Pharmaceuticals, and Teva Pharmaceuticals Industries.
Pradaxa – Drug manufacturing giant Boehringer Ingelheim first introduced Pradaxa in the U.S. in 2010. This blood thinner (dabigatran etexilate mesylate) quickly soared to sales of over $1 billion. From its position as one of the world’s leading anticoagulants, the drug began to find itself being linked to some very critical health concerns associated with serious internal bleeding that is sometimes fatal.
The manufacturer has only made one recall of a single lot of Pradaxa, which was in November 2012. Boehringer Ingelheim maintains the drug’s safety and efficacy and gives no indication of planning another recall.
Xarelto – This medication has also faced recall issues. Xarelto is a blood thinner that helps prevent strokes and blood clots. The Janssen unit of Johnson & Johnson recalled 13,500 bottles in October 2014 due to microbial contamination. The recall was issued after patients filed lawsuits claiming uncontrollable bleeding had caused deaths.
This class of drugs, Factor Xa, blocks specific clotting proteins. However, there is no antidote to reverse bleeding episodes. The recalled bottles were manufactured at Janssen’s plant in Puerto Rico. The same unit experienced something similar in 2013 when it was forced to recall 5,000 vials of the injectable version of Risperdal, an antipsychotic pill. Contamination in the form of a common mold was found in a sample bottle. Xarelto appeared in the U.S. drug market after Pradaxa, but rocketed past it in sales.
Helping Law Firms Receive Drug Recall Plaintiffs
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Instead of focusing your firm’s valuable time and attention on pursuing potential clients, let the Broughton Partners team use proven skills to target and connect you with injury victims who truly want information and are searching for the right legal representation. The professionals at Broughton Partners are committed to ensuring case quality and conversion. We will send retained plaintiffs and pre-package the qualified retainer with corresponding documents.
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