- Moderna recalls vaccine batch after foreign substance found in CDMO-made vial—again (fiercepharma.com)
The specter of particulates has forced another recall—this time on Moderna’s massively successful COVID-19 vaccine Spikevax—and the latest pull isn’t contract manufacturer Rovi’s first brush with contamination, either...Moderna...said it was recalling one Spikevax lot in Europe...The batch contains 764,900 doses made by CDMO Rovi that were deployed across Norway, Poland, Portugal, Spain and Sweden between Jan. 13 and Jan. 14. Moderna yanked the shots because of a “foreign body” found in one vial of the batch made at Rovi’s site in Spain...READ MORE
- 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
- Popular heart drugs tainted with carcinogens face a wave of lawsuits (pressherald.com)
The FDA has been coordinating a recall of adulterated heart medications since last July...Dozens of lawsuits have been filed against drug makers and sellers over widely prescribed generic heart medications tainted with potential carcinogens, the first claims in what some lawyers expect to be a wave of litigation...the carcinogen NDMA was discovered in valsartan manufactured by Zhejiang Huahai Pharmaceutical Co. The contaminated valsartan was sold to a number of major drugmakers and used as an ingredient in other popular cardiovascular therapies...Zhejiang Huahai and its affiliates are the primary targets of the lawsuits. Other companies named in the complaints include generic-drug giants Teva Pharmaceutical Industries Ltd. and Mylan NV, as well as CVS Health Corp., which operates large pharmacy and drug-benefit management businesses. Almost 40 defendants have been sued so far...READ MORE
- Blood Pressure Medicine Is Recalled (nytimes.com)
The Food and Drug Administration has announced a voluntary recall of a widely prescribed blood pressure medication made in China, reviving fears about the safety of imported drugs...Three companies that sell the generic drug, valsartan, in the United States agreed to recall it after the F.D.A. said it might be tainted by N-nitrosodimethylamine (NDMA), considered a probable human carcinogen. The agency is still investigating, but said the contamination was believed to be related to changes in the way that valsartan was manufactured...All of the valsartan that is being recalled was made in China by the same company, Zhejiang Huahai Pharmaceutical Co. Ltd. It is distributed in the United States by three companies: Major Pharmaceuticals; Teva Pharmaceutical Industries, Ltd.; and Solco Healthcare... Other companies that market the drug, not subject to the recall, are Sun Pharma, Mylan, Jubiliant, Aurobindo and Hetero...The safety of imported drugs has long been debated. The F.D.A. said it would continue to investigate the levels of NDMA in the recalled products, determine the possible effect on patients who have been taking them, and assess what measures can be taken to reduce or eliminate the impurity from future batches...
- FDA blasts California compounding pharmacy for facility ‘contaminated with filth’ (fiercepharma.com)
Auro Pharmacy has had a number of run-ins with FDA investigators...The FDA has had a long and troubled history with compounding pharmacies...sometimes those facilities bring it on themselves...Auro Pharmacies operated a veritable house of horrors at its...outsourcing facility, with ants in the sterile production areas and visibly dirty work surfaces, FDA investigators found during an August 2018 inspection...Those poor conditions could have produced supposedly sterile drugs that were "contaminated with filth,"...The FDA knocked Auro with a 10-observation Form 483 in August, 2018 that led to a voluntary recall of all the pharmacy's affected drugs and a stoppage to all sterile production...Even worse for Auro, the FDA followed up its August 2018 look-in with another round of inspections in September of last year that turned up most of the same sanitary issues, including "filth" on the end of hood-cleaning wands, and cracked and scratched production hoods...That inspection lead to a separate 11-observation Form 483 sent in October...READ MORE
- J&J recalls 33,000 bottles of baby powder as FDA finds asbestos in sample (reuters.com)
Johnson & Johnson said...it is recalling around 33,000 bottles of baby powder in the United States after U.S. health regulators found trace amounts of asbestos in samples taken from a bottle purchased online...The move marks the first time the company has recalled its iconic baby powder for possible asbestos contamination, and the first time U.S. regulators have announced a finding of asbestos in the product. Asbestos is a known carcinogen that has been linked to deadly mesothelioma...READ MORE
- Walmart and Aurobindo sued as litigation mounts over contaminated blood pressure drugs (fiercepharma.com)
Litigation is growing over tainted blood pressure medications with a class-action lawsuit now filed in Florida against Walmart and three drug companies that span the supply chain...In addition to the retailer, the lawsuit names Indian drugmaker Aurobindo, U.S. drugmaker ScieGen Pharmaceuticals and distributor Westminster Pharmaceuticals. It was filed in federal court in Florida against the four over the sale of irbesartan because the drug contained the impurity, N-nitrosodiethylamine...Hauppauge...and its distributor Westminster initiated a nationwide voluntary recall to the consumer level of all lots of unexpired irbesartan tablets because they had been made with the Aurobindo API and then shipped to Walmart. The FDA learned this summer that the suspected carcinogen...can show up in “sartan”-based drugs as a result of certain manufacturing processes...
- FDA pushes metformin recalls for 5 drugmakers after carcinogen contamination (fiercepharma.com)
After the FDA identified a likely carcinogen in samples of the broadly used diabetes med metformin, recalls appeared likely. Now it's official...The FDA said Thursday it had asked five metformin manufacturers to pull their extended-release metformin products, after pushing recalls of heartburn med Zantac and "sartan" blood pressure drugs for the same reason. A likely human carcinogen, N-Nitrosodimethylamine, was discovered in samples of all three...READ MORE
- Trump’s Drug Importation Policy Is Folly, Just Ask Canadians (forbes.com)Canadian Pharmacists Association renews call for federal government to protect drug supply in light of U.S. drug importation developments (pharmacists.ca)CPhA Drug Shortages and Recalls Surveys 2018 (pharmacists.ca)
The Trump Administration's Department of Health and Human Services has officially proposed legalizing the importation of drugs from Canada...Canadians’ reactions provide an important perspective demonstrating why drug importation will harm the U.S...Despite assurances from Prime Minister Justin Trudeau, Canadians are worried that the U.S. proposal will impose severe costs on Canadians. Their concerns are well founded. Typical of their reaction, the Canadian Pharmacists Association has noted that...the Canadian medicine supply is not equipped to support both Canadian and U.S. consumers, and will make existing drug shortages in Canada even worse, disrupting patients’ access to their medications. Drug shortages have ‘greatly increased’ in the last 3-5 years according to a newly released survey of Canadian pharmacists...READ MORE
- Teva to recall certain blood pressure medicine in U.S. (reuters.com)
Teva Pharmaceutical Industries Ltd is recalling certain combinations of blood pressure drug valsartan in the United States following the detection of a probable cancer-causing impurity...The...drugmaker will recall all lots of amlodipine-valsartan and amlodipine-valsartan-hydrochlorothiazide combination tablets due to an impurity in an ingredient made by an India-based unit of Mylan, the U.S. Food and Drug Administration...The European Union last week effectively banned here sales of valsartan made by the Mylan India unit after some batches were found to contain the same impurity, N-nitrosodiethylamine...