Why Medicines Are Sometimes Recalled

Drug recalls happen from time to time when safety to the public comes into question and injuries occur. Before becoming available to the consumer, all medicines are rigorously tested to make sure they are safe and effective. This is handled by the Food and Drug Administration in the United States. In addition to monitoring the medicine once on the market, the FDA works closely with the drug makers to ensure their continued safety. There may be drug recalls if a problem is discovered or a medication’s safety is questioned.

Who Recalls a Dangerous Drug?

In many cases, the company itself recalls a medication voluntarily when they receive complaints of injuries and possible fatalities. However, if the evidence is strong enough and the company does not recall that medication, the FDA requests that the medicine be withdrawn from the market. 

What Issues Can Result in Drug Recalls?

A number of issues can result in the recall of a medication, including:

  • Safety issues: Many drug recalls are placed each year for safety issues when they are found to contain serious side effects or can cause problems in the future. For example, Zantac, which is used to treat heartburn, was found to possibly result in multiple types of cancer such as that of the bladder, colon or stomach. Another recalled drug was Elmiron, used to treat bladder problems, when it was discovered that it had frightening side effects on the eyes such as pain, blurred vision and dark spots in the vision.
  • Poor manufacturing: Drugs that are manufactured poorly can end up causing serious injuries to the patients who use them. For example, products that are required to be sterile and aren’t can result in infections that are serious and potentially fatal. As an example, Edge Pharma recalled some of its sterile products such as lidocaine, methotrexate and others because a processing error may have adversely impacted the medications, making them unsafe.
  • Contamination: Contamination of a drug during the manufacturing process or distribution can make it unsafe for use. Although issues are fairly common in food products, they also occur with medicines. For example, Viona’s metformin Hydrochloride Extended-Release Tablets, used to treat Type 2 diabetes, was recalled due to an impurity found in one of its ingredients. In addition, Senna syrup, produced by AvPak and used as a vegetable laxative, was recalled due to possible microbial contamination. 
  • Mislabeling: Mislabeling of a drug can cause adverse side effects in those with allergies or may be ineffective. A recall nationwide was placed for Acetaminophen Extra Strength Tablets due to the drug label being incomplete. 

What if I Am Taking a Recalled Drug?

Over-the-counter drugs that are being recalled should be immediately stopped. If a recall is issued, you may be able to return the product and request a refund from the store where you purchased it. If you are prescribed one, your pharmacist or physician may suggest an alternative. Further information can also be obtained by contacting the manufacturer’s hotline. For replacement information on recalled prescription drugs, contact your physician or pharmacist as soon as you can.

Call the Olinde Law Firm

If you have been affected by drug recalls. Call the Olinde Law Firm for help. Contact us at (800) 587-1889 or reach out to us online. We can schedule a free case review where our legal team will examine your case, answer your questions and discuss how you will get the compensation you deserve.