Drug Recall Frequency

October 2021 : Cleanrooms & Compounding - Vol.18 No. 10 - Page #3
Category: Cleanrooms/Modular Cleanrooms

Recalls of compounded sterile products (CSPs) decreased again this year, driven by an ongoing decline in the number of CSP recalls from outsourced vendors. Most facilities have a recall system in place and these systems garner high marks from their users. More than 60% of facilities experiencing a recall over the past year were able to identify all of the patients who received the affected products.


More than 8 out of every 10 facilities has a system in place to identify recalled products used in compounding.


In-house recalls remain relatively rare; just 5% of facilities had to conduct a recall of an in-house compounded CSP over the past year. While recalls of outsourced products are somewhat more common, their frequency is on the decline. Just 13% of facilities recalled an outsourced CSP over the past year, down from a high of 41% 3 years ago.

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