Monday 25 January 2021

Recall trends and the primary causes for product recalls

Pharmaceutical product recalls relate to a type of flaw, ranging from mislabelling to contaminated ingredients. Generally, pharmaceutical companies conduct voluntary recalls in collaboration with a regulatory agency. This article looks at recent data for pharmaceutical recalls pertaining to the US and Europe, both as overall trends and in relation to specific occurrences. The assessment suggests that the rate of recalls is increasing.

Tim Sandle has written a new article:

Recall trends and the primary causes for product recalls, GMP Review, 19 (2): 4-9

The types of pharmaceutical products that undergo a recall are as varied as the available products on the market. They include over-the-counter, prescription and compounded drugs, ranging from tablets and capsules, injectable drugs, liquids, lotions and creams, and many more. Similarly, the reason for recalls are equally varied although there is more commonality in terms of the general types of problems that trigger recalls to occur.

The leading causes of pharmaceutical recalls are sterility, the presence of particulate/foreign matter, and failed specification testing, according to figures from the US Office of Pharmaceutical Quality. Every recall is different, so the financial impact varies greatly. It is based on a number of factors, including the number of units affected and the global reach of the recall. There are also indirect costs that need to be factored in. For example, if pharmaceutical companies don’t work with partners to execute the recall, their internal staff must step in at the expense of their usual duties.

This article presents the main types of recalls occurring within the US, Europe and other territories, noticing some differences in trends and approaches to recalls.

For details, please contact Tim Sandle

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Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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