UPDATED: Fewer recalls in Q1, but units pulled rocket with Novartis OTC issues

There was a big drop in drug recalls in the first quarter of the year, although the number of units affected was up 63%, according to an index that tracks them.

According to the most recent report from ExpertRecall, there were 69 pharmaceutical recalls in the first three months of 2012, the lowest level in the last 5 quarters it has tracked them. That is in contrast to recalls for medical devices which hit a 5-quarter high. The drop in drug recalls represents a 29% decline from the last quarter of 2011, although the number of units pulled off shelves was more than 150 million, a huge increase over the previous quarter.

The report says that 55 recalls involved prescription drugs and 14 were for over-the-counter (OTC) products. While there were far more prescription drug recalls, the OTC recalls affected the vast majority of the units being pulled from shelves.

In other findings:

- 6 recalls were classified as Class I recalls, affecting 3% of the units.

- Of the 150 million recalled units, 141 million were classified as OTC products.

- 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.

The report does not identify what companies or products were involved in the recalls. The most prominent recall in the first quarter in terms of depth and breadth was when Novartis ($NVS) in early January ordered the recall of millions of units of such OTC products, including the entire line of Excedrin, as well as NoDoz, Bufferin and Gas-X Prevention products. Among other problems, there was a chance that chipped particles of one drug made it into the bottles of other drugs.

The recalls followed the December closure of its plant in Lincoln, NE, where the FDA found a long list of manufacturing and packaging problems, where investigators found unclean lines and more than 1,300 consumer complaints that had not been addressed. Originally, remediation at the plant was expected to be completed mid-year but during its earnings call in April, executives said it is taking longer than expected.

And the problems at the plant were responsible for some of the prescription drug recalls. Endo Pharmaceuticals ($ENDP) and GlaxoSmithKline ($GSK), as well as other companies, recalled products that also were made at the plant. Even veterinary drugs made there had to be returned.

So what can companies learn from the most recent ExpertRECALL report? Mike Rozembajgier, vice president of Recalls for Stericycle ExpertRECALL, in an interview with FiercePharmaManufacturing, didn't have too much insight, other than companies probably could use the services of his firm, which helps with the logistics and record keeping of recalls.

"Due to market movement and regulatory actions, it is hard to predict what will happen quarter-to-quarter or even year-over-year," Rozembajgier, said. "But the numbers mean there were more products that needed to be taken out of the market faster."

He got that right.

- here is the ExpertRECALL drug recall index

Related Articles:
Novartis adds OTC drug plant to GMP fix list
FDA report shows deep problems at closed Novartis Consumer Health plant
GSK pulls blood pressure pills made at Novartis plant
Novartis plant disruptions affect pet treatments
After quiet Q4, device recalls surge in 2012

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