After seeing a 40% drop in European pharmaceutical recalls in 2020, the number of events rose 48% to 372 for 2021. The most common cause was safety, which accounted for 123 pharmaceutical recalls for the year. This was followed by failed specifications (56), quality (49), mislabelling (38), and foreign materials and contamination (35). This represents a big spike in product recalls for foreign materials and contamination, which were cited for only eight events last year.
France was the top country for both origin and notification of pharmaceutical recalls, with 108 in each category. The UK was second with 64 recalls both as the country of notification and the country of origin. There were no Class I recalls last year across the EU or the UK. Most (87%) were not assigned a Class. There were 20 pharmaceutical recalls classified as Class II, 11 as Class III, and 18 as Class IV for the year.
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