6 Common Culprits of Pharmaceutical Recalls

By Staff Writer

When you take prescription medication or over-the-counter (OTC) drugs, you believe it will help you recover or cope with the particular ailment you’re suffering.  However, there are times when the medication can cause you serious harm or death if it has been tainted in some way.

All medicine is supposed to be reviewed by the FDA, as well as the manufacturer, to test its effectiveness and safety before being made available to the general public.  Unfortunately, there are times when a problem is discovered after the medication has been released and a recall is necessary.

As FDA data indicates, the last two years have seen almost as many recalls (2,061) as the previous nine years combined (2,217)—and that figure only accounts for the first seven months of 2014.

Below are some common reasons for pharmaceutical recalls:

• Too much or too little API (active pharmaceutical ingredient). When the incorrect amount of an ingredient is in a drug, it can cause sickness, debilitating side effects or even death.

• Particulate contamination. This happens when inorganic material such as glass, silicone or stainless steel gets inside the medication.  Often this occurs from the wear and tear of the pharmaceutical processing machinery.

• Contamination with TBA (2, 4, 6-tribromoanisole). TBA is a pesticide with fire retardant properties and is a contaminant.  Read more details about how it became a common problem in 2009 and 2010 when customers complained of a musty smell when opening some of their medicine bottles.  This resulted in a mega recall for Johnson & Johnson with a total of 53 million bottles of Tylenol, Benadryl and St. Joseph’s Aspirin.

• Sterility failure in products. If a company fails to properly sterilize an intravenous medication, it can cause serious health problems. In 2008 through 2010, recalls occurred due to potential sterility failure in intravenous antibiotics, cancer drugs and migraine products.

• Poor packaging or mislabeling. Sometimes drugs have been recalled due to confusing or wrong instructions, as well as other mislabeling issues.

• Drug is not what it says it is. You may believe you are consuming a pain reliever when in fact it is something completely different.

This is a short list of reasons drugs may be recalled.  If you have taken a prescription or OTC medication that you believe was contaminated or has been recalled, immediately contact an experienced personal injury attorney to discuss your legal rights. The Tennessee pharmaceutical liability lawyers at Gilreath & Associates are available now to schedule your free case evaluation.

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