Class I drug recalls soared in Q2 according to new research

08-Aug-2017 - Last updated on 09-Aug-2017 at 09:16 GMT

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More drugs were recalled in the US in the three months to the end of June than in any period since Q4 2014 according to analysis by Stericycle ExpertSolutions.

According to the firm – which provides collection, logistic and handling services for drug manufacturers - 86 drug products were withdrawn in the second quarter, a 6% hike on the equivalent period last year.

Some 11.6m of the withdrawn drugs were classified a class I recalls, which is used when the US Food and Drug Administration (FDA) believes there is a significant risk of serious adverse consequences or death, which is the highest number of class I recalls since 2004.

Stericycle ExpertSolutions spokesman Michael Good said: “The number of Class I units recalled in Q2 increased nearly 45 thousand times over the previous quarter. That is a tough pill to swallow.”

"Class I is the most critical type of recall, so to see increases across multiple industries where serious adverse consequences or death can occur is certainly concerning" continued Good.

Around 74% of withdrawn products were recalled due to potency issues, either subpotency or superpotency, compared to 9.1% in Q1 2017.

The average recall size was 464,705 units – the highest level since Q4 2014 and third highest since Q4 2011.