Johnson & Johnson just announced recall No. 5. The company said it would recall four lots of Benadryl allergy pills and one lot of Extra Strength Tylenol--lots that the company "inadvertently omitted" from a previous recall launched back in January.
It's yet another black eye for McNeil Consumer Healthcare, the J&J unit that makes over-the-counter drugs. First came a series of three recalls of adult drugs. Then there was the big recall of 43 children's drugs made at McNeil's Fort Washington, PA plant. That was followed by a particularly unflattering FDA inspection report--the one that prompted that fourth recall.
Congress announced it would investigate. J&J and FDA officials were called to testify at a hearing. FDA said McNeil had shown "a pattern of noncompliance." And now, as you know, the House Committee on Oversight and Government Reform is collecting thousands of pages of documents from the company, including some internal communications that suggest McNeil's top executives were directly involved in a "phantom recall" of faulty Motrin tablets that preceded the very first official recall in the series.
This latest recall involves drugs that should have been part of that earlier recall, which was prompted by consumer complaints of a musty or moldy odor from meds made at a Puerto Rico plant. The odor, which could cause nausea or diarrhea, was traced to contamination with a chemical called 2,4,6-tribromoanisole (TBA). As with the previous recall, the current lots of Benadryl and Tylenol aren't thought to pose a risk of serious adverse events. Except, perhaps, to J&J's reputation.