Global Pharma Healthcare is voluntarily recalling lubricant eye drops owing to potential contamination. The recall is a result of an investigation by the Centers for Disease Control and Prevention (CDC) into a cluster of multi-state infections linked to the use of the product. CDC suspects that a cluster of Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended…

In recent years, a number of drug companies have carried out prominent recalls of hypertension, heartburn and diabetes medications due to the presence of nitrosamines, organic compounds shown to cause cancer in animal studies. The problem could cost Big Pharma companies billions of dollars, but proving the cancer-causing role of nitrosamines in drugs may be difficult.…

The FDA has classified a recall of a Baxter Healthcare product used to deliver hazardous drugs such as chemotherapeutic agents Class 1, indicating that it could cause serious adverse health consequences or death. The recall covers all lots with product code 2R8403 distributed from October 14, 2020 to June 30, 2022. There are Baxter announced…

In Q2 2022, the number of recalled units in the U.S. pharma industry dropped sharply. In the first quarter of the year, drug makers recalled more than 435 million units. However, the number of recalled units in Q2 2022 was 20.5 million, according to the Sedgwick Brand Protection Q2 2022 recall index. “It was definitely a…

The Canadian division of Taro Pharmaceuticals (NYSE:TARO) has announced a voluntary Type 1 recall of six lots of Taro-zoledronic Acid Injection. Type 1 recalls, according to Health Canada, refer to products that could cause serious adverse health consequences or death. It corresponds to Class 1 recalls from the FDA. Taro Pharmaceutical‘s consumer-level recall covers 5 mg/100…

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,…