A report on food, drug and device recalls released Monday paints a mixed picture as it relates to product safety.
Based on data from the U.S. Food and Drug Administration’s data and the Consumer Product Safety Commission, the quarterly recall index compiled by Stericycle ExpertRECALL found that the number of devices recalled in the first quarter of the year fell 14 percent from the same quarter a year ago. At the same time, it increased a whopping 161 percent from the previous quarter, which was unprecedentedly low. Further, the 277 recalls in the first quarter involved nearly 82 million units. That is 89 percent higher than the first quarter of 2011, but 508 percent higher than the last quarter of the year.
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Here are a few more data points regarding first-quarter medical device recalls from the report:
- The number of units affected by first-quarter recalls hit a five-quarter high.
- One-third of companies facing recalls in the first quarter of 2012 were involved in more than one recall.
- Forty-eight companies initiated more than one recall in the first quarter.
- Only 4 percent of recalls in the first quarter of 2012 were classified as Class I. Eighty-eight percent of medical device recalls in the first quarter were classified as Class II recalls, which accounted for 99 percent of all units recalled.
The story is a little bit better when it comes to pharmaceutical recalls.
In that industry, first-quarter recalls numbered 69, which represents the lowest number of recalls in the past five quarters. In fact, the recalls represent a 29 percent drop from that of the last quarter of the year and a 28 percent reduction from the same quarter a year ago.
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Still, even as the absolute number of recalls were dropping, they had larger footprints in terms of affected units. In the first quarter, the number of recalled units stood at a five-quarter high — 150 million units. That represents a 63 percent increase over the previous quarter.
Here are some additional data from the report:
- Fourteen recalls affected over-the-counter (OTC) products while 55 recalls affected prescription (Rx) products.
- FDA Enforcement Reports documented more than 150 million recalled units, including more than 141 million that were classified as OTC products.
- Six recalls were classified as Class I recalls — the lowest number of recalls with that distinction compared with the previous four quarters. These recalls affected 3 percent of all units recalled.
- According to FDA Enforcement Reports, two recalls affected more than 10 million units, four recalls affected between 1 million and 5 million units, and the remaining affected fewer than 1 million units.
- Recalls by 52 companies were documented in first-quarter Enforcement Reports. Among these companies, nine faced more than one recall.
