Recalls

Fresenius Kabi has announced a three-year plan to add GS1 Data Matrix barcodes to its pharmaceutical portfolio.  GS1 Data Matrix barcodes are also known as 2D barcodes.  The company manufactures a range of vials, syringes, IV products and parenteral nutrition products.   The Lake Zurich, Illinois–based company says the decision will reduce the need for manual data entry…

The presence of toxic nitrosamine impurities in drug substances and drug products has become a significant focus for the pharmaceutical industry following their identification above permitted limits in common drug products prescribed for type 2 diabetes, high blood pressure and heartburn. To learn more about the situation, we interviewed David Elder – CMC consultant –…

FDA has sent warning letters to four companies for illegally marketing honey-based products with unlisted active drug ingredients found in the erectile dysfunction drugs Cialis (tadalafil) and Viagra (sildenafil). The agency said it confirmed the presence of contaminants in the products through laboratory testing. The agency sent the warning letters to the following companies: Thirstyrun…

FDA worked with pharma companies to avert a record number of drug shortages in 2021 based on a recent report to Congress that tracked data starting in 2012 when the FDA Safety and Innovation Act (FDASIA) was passed. In 2021, 115 manufacturers notified the FDA of 777 potential drug and biologic shortages. Ultimately, the agency worked to…

Novartis (NYSE:NVS) announced that it had voluntarily stopped the production at radioligand therapy plants in Ivrea, Italy and Millburn, New Jersey, over possible quality concerns. In a statement, the company explained it had made the decision “out of an abundance of caution due to potential quality issues identified in its manufacturing processes.” As a result,…

Amazon appears to have growing troubles around herbal supplements sold on its site. The online retail giant has informed the herbal supplement company Celebrate Today (Brentwood, New York) that its Red Mammoth pills were tainted with sildenafil and tadalafil, both of which are FDA-regulated drugs for erectile dysfunction and other conditions. Similarly, Amazon announced that…

Gilead Sciences (NSDQ: GILD) has announced that it has identified tampered and counterfeit versions of its HIV drugs Biktarvy and Descovy in the U.S. supply chain. Biktarvy is a blockbuster drug cocktail, raking up $7.26 billion in sales last year. 2020 sales of Descovy were $478 million. Foster City, Calif.–based Gilead said that unauthorized distributors…

Pfizer (NYSE:PFE) has stopped international shipments of the smoking-cessation drug Chantix (varenicline) after concluding it had elevated levels of a potential carcinogen. The substance in question, nitrosamines, are organic compounds thought to cause cancer in various organisms. “We believe the benefits of Chantix/Champix outweigh the very low potential risks, if any, posed by nitrosamine exposure…

Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out. The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination.…

GlaxoSmithKline (LON:GSK) paid nearly $10 billion in inflation-adjusted financial penalties between January 2003 and December 2016, the highest tally for any drug company, according to research published in JAMA. That sum was more than any other in a sampling of 26 companies paying fines inside the U.S. Pfizer (NYSE: PFE) was next in line with…