How Pharmaceutical Packaging Can Lead to Product Recalls

How Pharmaceutical Packaging Can Lead to Product Recalls

March 14th, 2022 // 2:20 pm @

Pharmaceutical manufacturers generally pay close attention to ensure they are compliant with GMP standards and FDA regulations when manufacturing drug. But sometimes, the packaging of the pharmaceutical can be an afterthought. It is estimated that as many as 50% of drug recalls are because of errors with product labeling and artwork on the packaging. This is certainly an area that pharmaceutical companies should never ignore.

If your company mislabels or poorly packages a drug, there are several risks for the company and the end user:

  • Patient safety: Errors in the labeling can lead to misuse of the drug.
  • FDA compliance problems: FDA has strict standards on packaging for pharmaceuticals.  Several items must be on the label for it to be in compliance. If you do not comply, FDA may issue a product recall.
  • Costs of drug recall and fines: The cost of having to do a drug recall because of product labeling is very high.
  • Damage to image: Drug recalls are very public in nature and can have a negative effect on the reputation of the company.
  • Time lost dealing with issues: The time you must spend looking into what caused the error with labeling is time you could have spent on developing and investing in other drugs.

According to FDA guidance, drug packaging and labeling should include the following:

  • The most vital product information should be on the most easily visible part of the package.
  • Labels need to be easily readable for the user and easy to understand.
  • Labels on containers need to be unique and not be too similar to packaging for other products.
  • Product codes need to be different enough to make them easily distinguishable from other drugs.
  • Blister packs need to have several pieces of information about the product, such as the generic name and trade name, date of expiration, strength, manufacturer and bar code.

Some of the most common product labeling errors include:

  • Gross errors: These can happen when essential information is not on the label artwork. This sort of error often happens when FDA regulatory requirements have changed but the drug manufacturer has not changed the artwork in response.
  • Context and meaning mistakes: Label artwork information is given in a vague way. A context or meaning error can happen even if wrong punctuation is used.
  • Content errors: Major errors in detailed content of the product artwork. Could be incorrect use of symbol on the label.
  • Technical mistakes: Functional aspects of the product artwork, such as the barcode for the product.

Industry insiders think FDA is soon going to require drug manufacturers to have more unique codes on their product packages to enhance control over the product supply chain. It is important to pay close attention to the packaging and labeling on your drug to ensure you do not have to do an expensive FDA recall in the future.




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