FDA cites botches in Tylenol odor probe

The McNeil Tylenol musty medication recall took another serious turn late last week: The FDA issued a warning letter after finishing in early January a several month inspection of the Las Piedras, Puerto Rico, facility involved in shipping the products blamed for nausea, stomach pain, vomiting and diarrhea.

"The Agency is concerned about the response of Johnson & Johnson (J&J) to this matter. It appears that when J&J became aware of FDA's concerns about the thoroughness and timeliness of McNeil's investigation, whether all potentially affected products had been identified, and whether the recall was adequate in scope, J&J did not take appropriate actions to resolve these issues," the letter states.

The J&J unit came up short on three main counts, according to inspectors.

First is the drugmaker's failure to track down all deviations from manufacturing spec, even for products already shipped. In addition, its investigation excluded other batches of the same product and other products that might have been associated.

Second, the regulator notes the absence of timeliness in McNeil's actions. The company waited a year to notify the FDA after first learning that people were sickened, reports the LA Times. The warning letter states, "Quality management should have ensured the start of chemical testing far earlier."

Its failure to do so accounts for the delay oddities reported earlier, which stalled identification of the problem, extended the duration of consumer exposure, and necessitated the multi-stage recall that began in early November 2009 with the recall of certain lots of Tylenol Arthritis Pain Caplets. The recall was extended in December to include all lots of the arthritis med and expanded last week to about 50 million bottles of Tylenol, Motrin and some other OTC products (including, ironically, the popular stomach-distress medication, Rolaids).

The final FDA count cited in the warning also concerns timeliness: In violation of code, McNeil filed no NDA-Field Alert Reports within the required three days of its notification of the contamination.

- here's the warning letter
- read the LA Times article
- here's the 14-page recalled products list
- see our top 12 GMP violations of 2009