Regulatory Focus™ > News Articles > Report Shows Big Increase in Pharmaceutical Recalls Led by Compounding Pharmacy Troubles

Report Shows Big Increase in Pharmaceutical Recalls Led by Compounding Pharmacy Troubles

Posted 16 May 2013 | By

Recall reporting and consulting firm Stericycle is out with its latest quarterly report regarding the state of industry recalls, showing a disturbing trend in recalls led by compounding pharmacies and large-scale medical device problems.


Pharmaceuticals as a category is made up of two types of products: Drugs manufactured under traditional conditions, such as in a large-scale manufacturing facility, and drugs that are compounded, often on a one-off basis.

Compounded drugs have been the subject of a flurry of recalls in recent months as the US Food and Drug Administration (FDA) moves to crack down on the sector in response to congressional pressure. The agency's inspections, Form-483 reports and warning letters have led to a huge number of recalls.

Stericycle's data shows that the extent of the recalls is far more extensive than some might realize. "This quarter, a compounding pharmacy faced the most recalls of any other company with 13 events," the company wrote in its report.

"In fact, data shows compounding pharmacies have topped the list of companies issuing the most recalls for the last two quarters," Stericycle added in a press release. "FDA Enforcement Reports in the first quarter of 2013 documented 107 drug and pharmaceutical recalls, higher than the average number of events from last year.  And given only six of the 107 document recalls affected over-the counter products, we continue to see compounding pharmacy recalls making headlines in the news."

Pharmaceutical recalls increased 32% from the fourth quarter of 2012, when there around 80 recalls. However, even with the increase, recalls are still down significantly from Q3 2012 when there were more than 165 recalls. The first quarter of 2013 only had 107.

Because many of the recalls were related to compounding pharmacies, which tend to produce products in smaller numbers, the total units affected by the recalls only rose from 11.7 million to 13.1 million-a disproportionately small increase of 12% relative to the 32% increase in total recalls. The recalls tended to be more serious, however, with 14 of the 107 classified as "Class I" recalls with a high potential for patient harm or death. That was the largest amount in the last five quarters, and a 100% increase from the previous quarter.

Medical Devices

Devices were a great deal calmer than their pharmaceutical counterparts in Q1 2013.

Device recalls were perfectly flat relative to the previous quarter, with 315 medical device recalls in both quarters. Stericycle noted that this is still an increase relative to the 277 seen in the first quarter of 2012, but it is down significantly from Q3 2012, when there were more than 400 recalls.

However, even as the number of recalls stayed flat, the number of units affected increased nearly 100% from 10 million units to 19.4 million in Q1 2013. That increase was primarily attributable to a few major recalls, such as one affecting nearly 5 million units, and three affecting 1 million each.

As with pharmaceutical products, the majority of recalls were either classified as low- or moderate-risk (Class III and Class II, respectively). Class I recalls were relatively flat compared with previous quarters.

For Stericycle, the data also held one other important point: "For the third straight quarter, nearly forty percent of medical device companies named in FDA Enforcement Reports were involved in two or more recalls."

"Those within the industry should take this time to make sure that they have procedures in place to properly assess the scope of any recall event," the company concluded. "By ensuring that all potentially affected products are accounted for and collected in an efficient manner, customers and patients will be much more likely to remain loyal to a brand."

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