Recalls Increase Slightly Third Year in a Row

Drug recalls increased for the third straight year, with companies pulling six percent more products in 2014 than the year before and foreign particles being the top culprit.

The FDA recorded 337 pharmaceutical recalls in 2014, above last year’s total of 315, and up from 291 events in 2012, according to an analysis of agency enforcement reports.

The leading cause for recalls by a wide margin was foreign particles in the drug product, resulting in 55 recalls. Drugmakers reported recalling products containing such things as hair, steel and glass. That figure is well above last year’s total of 19 recalls attributed to foreign particles.

Drug products that failed impurity testing and those with labeling errors tied for second place, with each causing 31 recalls. Subpotent drugs (22 recalls) and products that failed to dissolve properly (20 recalls) accounted for the rest the top events.

One startling trend last year was the spike in the most serious Class I recalls, which at 47 recalls was 45 percent above 2013’s total of 25.

Compounding pharmacies were responsible for almost 8 percent of the overall total, accounting for 28 events in 2014. That figure is slightly below the previous year’s total of 28 recalls. The cause of a majority of compounding recalls was a lack of sterility assurance of the compounded products. The agency has clamped down on compounders since a 2012 deadly outbreak of fungal meningitis attributed to poor quality drugs.

Biologic recalls continued at a low rate in 2014, with only four drugs or vaccines being pulled. Similarly, in 2013, only five biologic products were recalled.

The three-year increase comes as the FDA is changing how it plans to approve some recalls. The agency said recently it will decentralize approval authority for Class I recalls, eliminating the requirement that an associate commissioner approve the Class I recalls and giving that responsibility to CDER.

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