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What type of packaging errors result in drug recalls?

When many individuals hear about drug recalls, they immediately default to the thought of potential contamination, the discovery of new side effects or some actual problem with the prescription or over-the-counter medication itself. People seldom think about how the design or marketing of a product may lead to a recall. There are many instances in which drug manufacturers or federal officials recall these products due to ineffective packaging.

Data analyzed by researchers at captures how at least one-half of all drug recalls may be attributable to packaging artwork or labeling errors.

United States Food and Drug Administration (FDA) has guidelines that drug manufacturers must follow when packaging and labeling their products.

The federal agency requires the content on product labeling to be clear enough that a layperson can understand what it says. It must be easily readable and along an easily visible section of the packaging. Drug manufacturers must also be deliberate as to how they label and number their different products. The FDA has a requirement, for example, that any given package’s label has to be easily discernable from any other one. Any product codes listed on the labels must also be different enough that they’re not easily confused.

The FDA also has specific requirements in place for blister packs. They must feature both the trade and generic name for the drug, the strength of the medication, a bar code, the manufacturer’s name and its expiration date.

Some of the more common packaging errors that occur happen because manufacturers or regulators notice a problem with the package’s barcode or improper use of a symbol or punctuation. If the FDA asks a manufacturer to change the artwork on the packaging and they fail to do so, then this may also result in a recall.

Federal officials and drug manufacturers often recall drugs after multiple patients suffer severe adverse reactions after taking it. Incorrect dosage instructions, side effect warnings and poorly written descriptions are some of many packaging problems that can result in a medication’s removal from the market.

Many drug manufacturers may be able to remedy a packaging error and quickly get their medication back on the market. Someone can easily suffer adverse consequences before this happens, though. An attorney can advise you of your right to recover compensation if your health deteriorated after taking a poorly-labeled medication here in Baton Rouge or anywhere else in Louisiana.

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