Drugs

Drug, Medical Device Recalls Down

Pharmaceutical recalls decreased 7.8% to 94 in the first quarter of 2019, higher than 19 of the last 21 quarters, according to the Stericycle 2019 Q1 index. The report says that recalled units decreased 75.3% to just under 13 million, lower than six of the last nine quarters. Some 10% of the recalled units were Class 1, 82% were Class 2, and 8% were Class 3.

Stericycle says there were more than one million Class 1 units recalled for the second consecutive quarter. The last time there were two consecutive quarters with at least one million units recalled were Q2 and Q3 in 2015, it says.

The top causes for drug recalls were failed specifications (26.6%). CGMP deviations (22.3%), mislabeling (14.9%), sterility (8.5%), and foreign material (6.4%). Some 77.7% of all pharmaceutical recalls were nationwide.

Medical device recalls decreased 41.4% to 164, the lowest since Q4 2017, and second lowest since Q4 2011. Stericycle says recalled units decreased 16.2% to just under 135 million, the third highest since at least 2005.

There were more than one million Class 1 recalls for the third consecutive quarter. The last time there were three consecutive quarters with at least one million units recalled was Q2 to Q4 2014.

The leading medical device recall causes listed in the report were software issue (37), mislabeling issue (31), quality issue (21), and sterility (15).

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Gupta Raises Concerns About Overton’s Independence, Ideology

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