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Report: Recall Trends Generally Flat Through First Half of Year

Posted 21 August 2012 | By Alexander Gaffney, RAC 

Consumer product recalls initiated for pharmaceuticals and medical devices remained largely flat during the second quarter (Q2) of 2012, according to a new report published by recall firm Stericycle.

The report, part of a long-running analysis published by the company on a quarterly basis, looks at product recalls in the US under the jurisdiction of the US Food and Drug Administration (FDA). While general trends were relatively flat, the company noted that the number of total products recalled varied significantly from the previous quarter for both products and in opposite directions.

Medical Devices

There were 242 recalls initiated for medical devices during Q2, or 13% fewer than the 277 initiated during Q1. Though fewer in number, the recalls affected 123.5 million units-the highest amount in the last two years and 50% higher than the previous quarter.

As with previous quarters, just a small handful of the products accounted for a disproportionate numbers of recalls. Three products, for example, affected more than 30 million units.

Some companies also faced multiple recalls, with just 142 companies accounting for 242 recalls, or an average of 1.7 recalls per firm affected.

The severity of the initiated recalls also trended closely with previous quarters. Class II recalls, or those of a moderate risk to patients, represented the overwhelming majority of recalled products. Class I recalls, which represent the highest theoretical risk to patients, represented just 1% of recalled units and 7% of all individual recalls.

Pharmaceutical Products

Pharmaceutical products stayed flat through Q1 and Q2, with FDA documenting just 69 recalls for each respective quarter. The total number of products affected by the recalls plunged in Q2, however, affecting just 10% of the products.

Similar to its recalled counterparts in the device sector, just six pharmaceutical products accounted for more than 5 million total recalled units. Fifty-eight recalls affected fewer than 500,000 units each. Thirteen companies faced more than one recall.

As with medical devices, Class II recalls continued to account for the majority of recalls (45), while Class I recalls accounted for just six.

Meanwhile prescription drug products accounted for 80% of recalled products, while the remaining 20% were over-the-counter products.

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