New cause found in most recent Tylenol recall

The adjective pool has been drained through overuse during so many J&J recalls; here, then, is a colorless report: Johnson & Johnson's ($JNJ) McNeil unit has initiated a recall of 2.5 million packages of Tylenol Cold Multi-Symptom Nighttime rapid release gelcaps.

This recall stems from a "slightly higher than expected" presence of chlorpheniramine ammonio acetate (CPAA) found in some capsules during product sample monitoring. CPAA is formed from the combination of two product ingredients. Certain levels are expected, according to the Tylenol notification.

The excess appears to have caused no health problems, and the recall is at the wholesale and retail levels. Product is not being called back from consumers.

The CPAA recall instigator is a new twist. Most Tylenol recalls began with musty smelling drugs, and then some with labeling errors. The excess CPAA raises questions about why this new cause discovery comes so late, after all the investigating and remediation work that J&J says it has done since the whole mess began in September 2009.

The callback represents the 26th in the Wall Street Journal's "J&J Recall Watch;" it pulls in at number 16 on our more tightly focused Tylenol-only recall list.

Barring details unmentioned by McNeil, the recall supports the theory of a systemic QA meltdown--which J&J CEO Bill Weldon (photo) has consistently denied--apparently reaching far corners of J&J with recent recalls outside the McNeil group of Risperdal, Prezista, surgical wound-draining devices and insulin pump cartridges.

"Manufacturing failures emerge from the line; quality failures emerge from the boardroom," Donald Riker, president at healthcare industry consultancy On Point Advisors, told us in May.

- see the column
- here's the recall notice

Special Report: The Battered Brand: A Tylenol Recall Timeline