J&J reorganises McNeil as recalls keep coming
pharmafile | April 5, 2011 | News story | Manufacturing and Production | J&J, JJ, Johnson & Johnson, McNeil, TBA, TCA, Tylenol, manufacturing compliance, pharma manufacturing, recalls, tribromoanisole, trichloroanisole
Johnson & Johnson has announced a major reworking of its troubled McNeil Consumer Healthcare unit, just as quality problems force yet another recall of its over-the-counter medicines.
J&J has split the US OTC medicines business into a standalone unit – separate from other consumer products such as skincare and oral health brands – to help achieve closer supervision of its quality and compliance functions. The consumer health division will also be split into four regional areas: North America, Latin America, Europe/Middle East/Africa and Asia-Pacific.
Meanwhile, J&J has also appointed new leadership for the unit. The US division will now be overseen by J&J veteran Patrick Mutchler, while current consumer health bosses Marc Robinson and Peter Luther have been moved to other roles, according to a Wall Street Journal report.
News of the revamp came shortly after two of McNeil’s manufacturing facilities in Fort Washington, USA, and Las Piedras, Puerto Rico, were placed under a consent decree by the FDA for persistent failures to meet quality standards.
J&J has had to undertake a string of product recalls affecting millions of over-the-counter medicines in 2009 and 2010 because of quality control issues at the two plants, along with another facility in Lancaster, Philadelphia.
Millions of products have had to be recalled by the company for a wide range of quality issues, including mouldy odour, variations in potency, contamination with wood and metal particles and sterility failures.
The latest recall involves one product lot of Tylenol 8-Hour Extended Release Caplets in 150-count bottles that had been distributed in the USA. Once again the problem was a musty odour caused by contamination with 2,4,6-tribromoanisole (TBA) and 2,4,6-trichloroanisole (TCA), likely to have leeched into the product from treated wooden pallets.
Phil Taylor
Related Content
Johnson & Johnson to acquire Shockwave Medical
Johnson & Johnson (J&J) and Shockwave Medical have announced that they have entered into a …
FDA approves J&J’s Opsynvi for PAH treatment
Johnson & Johnson (J&J) has announced that the US Food and Drug Administration (FDA) has …
Johnson & Johnson acquires Ambrx Biopharma for approximately $2bn
Johnson & Johnson (J&J) has announced that it has successfully completed its acquisition of Ambrx …
