- Walmart, CVS and Rite Aid pull 22-ounce J&J baby powder off shelves (reuters.com)
Three major U.S. retailers, including Walmart, are removing all 22-ounce bottles of Johnson & Johnson’s baby powder from their stores, following the healthcare conglomerate’s recall last week of some bottles due to possible asbestos contamination...CVS Health Corp said...it would remove the bottles from its online store as well, out of caution and to prevent customer confusion. The pharmacy chain said all other sizes of the talc would remain on its shelves...READ MORE
- Sun Pharma recalls more than 216,000 bottles after label leaches chemical (fiercepharmamanufacturing.com)
According to the most recent FDA Enforcement Report, Mutual Pharmaceutical, a division of Sun Pharmaceutical, is recalling 187,106 bottles of felodipine extended-release blood pressure tablets and 29,660 bottles of the antidepressant imipramine because the varnish is leaching benzophenone… during long-term stability testing, it found trace amounts of benzophenone in the drugs, which it said is unlikely to cause any adverse effects.
- China’s Zhejiang Huahai lambasted in FDA warning letter for putting profits ahead of safety (fiercepharma.com)
The Chinese API maker at the heart of a global scare and recall of blood pressure medicines has been savaged in an FDA warning letter for failing to uncover a suspected carcinogen in its APIs when a customer complained several years ago...The FDA said that when Zhejiang Huahai Pharmaceutical altered its manufacturing process in 2011 to include a solvent suspected of producing the impurity, it didn’t even consider that the changes might lead to the formation of mutagenic impurities in its valsartan APIs...“You failed to adequately assess the potential formation of mutagenic impurities when you implemented the new process,” the highly redacted warning letter says...Regulators in the U.S. and Europe continue to test products to try to ferret out all of the affected drugs. The FDA says there is very little risk of the impurities causing problems, and no adverse reactions have been seen...
- California lawmaker battles recall by anti-vaccine activists (newsdaily.com)
California lawmaker (Richard Pan, pediatrician) who made it harder for parents to opt out of vaccinating their children, a stance that earned him death threats, is now launching a campaign to save his job, days after the state certified a recall effort against him.
- China drug scandals highlight risks to global supply chain (cnbc.com)
The drug safety scandals...have underlined the risks to international consumers posed by weak oversight in China, the world's largest supplier of active pharmaceutical ingredients...The European Medicines Agency and the US Food and Drug Administration issued alerts over a cancer-causing ingredient used in a blood pressure medication, supplied by Chinese company Zhejiang Huahai, resulting in a recall of affected drugs...Then Beijing announced that hundreds of thousands of substandard vaccine doses had been sold in China, prompting a public outcry. Senior executives were arrested at the pharma company, Changsheng Biotech, which was also accused by authorities of forging data during the production of rabies vaccines...China is home to thousands of API producers, with exports worth $29bn last year...its producers supply ingredients for generic drugmakers such as Teva Pharmaceutical and multinationals including Johnson & Johnson and Novartis. About 80 percent of APIs used in the US come from China and India…Warnings to Chinese companies published by the FDA and EMA in recent years show that dozens have violated standards, mainly relating to record-keeping during the manufacturing process. In several cases the exporters shipped large volumes of product before the infractions were discovered...