J&J expands US OTC recall on more TBA contamination fears
J&J began 2010 as it ended 2009, by expanding a recall. In December 2009 J&J expanded its recall of Tylenol because of reports of a mildew-like odour. By January the recall had expanded to include a range of Tylenol products and other over-the-counter medications marketed by J&J.
J&J halts production at Pennsylvania after FDA QC criticism
Problems at J&J that emerged towards the end of 2009 continued throughout 2010. In May J&J stopped production at its site in Pennsylvania, US after an inspection by the US Food and Drug Administration (FDA). J&J aims to reopen the site in 2011.
However, earlier this month the FDA said the plant still faces problems. Also, Ed Towns, chairman of the House Committee on Oversight and Government Reform, said the recall of Rolaids this month is an indication J&J “continues to exhibit serious shortcomings” in QC.
“Musty odour” caused Pfizer to recall 191,000 bottles of Lipitor
Pfizer also initiated a recall after detection of a musty odour in 2010. Like the J&J case, 2,4,6 Tribromophenol, a chemical used on wooden pallets, was linked to the musty odour. Pfizer recalled a further 19,000 bottles of Lipitor yesterday following a complaint about an odour.
Lilly’s Puerto Rico API plant issued with FDA warning letter
Puerto Rico was, alongside musty, mildew-like odours, one of the big QC stories of 2010. J&J, GlaxoSmithKline and Bristol-Myers Squibb faced the consequence of manufacturing issues on the island, while the capability of the FDA’s district office was also questioned.
Eli Lilly was another big pharma to encounter problems on Puerto Rico. In February the FDA published a warning letter issued to a Lilly active pharmaceutical ingredient (API) production site on Puerto Rico. Lilly said it was “taking prompt action to address the Agency’s concerns”.
FDA: Apotex response to GMP warning “inadequate
The FDA issued Apotex with a warning letter stating Apotex’ responses to the agency’s concerns were inadequate and lacked sufficient corrective actions. Apotex sites Etobiocoke and Signet Drive, Canada were the focus of the warning letter which followed an import alert and recall.