However, the company stated that they are notifying distributors of the recall and are requesting that they notify their customs, consumers, and retailers. Because generic drug manufacturing is a very complex, highly regulated industry, it’s not easy for new manufacturers to immediately jump in, Tichy said. Even worse, when Akorn shuttered, it could no longer monitor the quality and safety of many of the drugs it had already distributed nationwide to retailers, medical facilities and consumers online. In early May, the FDA announced that Akorn was recalling drugs that had been distributed.
The clinic also had to get rid of any remaining Akorn products and notify doctors and patients about the recall. There have been supply crunches for heart medications, cancer treatments and ADHD medications in the U.S. and globally in recent years. Companies like Akorn face intense competition and declining profits and have been forced to lay off workers and cut costs to stay in business. The Lake Forest, Illinois-based drugmaker was responsible for producing 75 generic drugs, all of which were pulled from the market when the company closed down.
- The affected products are listed in Attachment I (human drugs) and II (animal drugs) of this release.
- Even with high demand for the products, the low cost of the drugs means generic drugmakers don’t make much money, according to David Gaugh, the interim president and CEO of the AAM.
- Consumers/distributors/retailers that have products which are being recalled should discard and contact their doctor.
- For example, antivirals can treat herpes, chickenpox, or influenza virus.
- Unlike brand-name drug companies, he said, generic drugmakers are not protected by patents that allow them to exclusively sell medications for a set period of time.
In some cases, the company was the sole supplier of particular products. “There’s nothing on this list that makes me say ‘oh my goodness, we’re in trouble’ because many of these medicines have been around for a long time and we have other generic manufacturers who make them,” Tsourounis said. She does acknowledge, however, that there could be some medications on the list that are not manufactured or produced by other companies. Akorn Pharmaceuticals, a generic pharmaceutical manufacturer and distributor that was based in Gurnee, IL, has issued a voluntary recall of various human and animal medications after it filed for bankruptcy and closed shop in February. The generic drug industry’s business model has become unsustainable for many manufacturers, said Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists.
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An FDA inspection found that the company did not follow proper protocol to prevent contamination of its products. In December, Intas Pharmaceuticals, a generic drug manufacturer based in India, suspended production after an FDA inspection last year cited numerous quality concerns. The suspension xcritical caused a widespread shortage of cisplatin, a chemotherapy drug used for a variety of cancers, including testicular, lung, bladder, cervical and ovarian. In 2021, 78% of the suppliers of active pharmaceutical ingredients were in China, India and the European Union, according to the FDA.
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New drug shortages increased by nearly 30% from 2021 to 2022, affecting 295 products at the end of last year, according to a March report from the Senate Committee on Homeland Security and Governmental Affairs. The drug shortages are affecting cancer patients who are in desperate need of chemotherapy drugs and people in intensive care units or emergency rooms who need certain generic intravenous medications, https://xcritical.online/ which are in tight supply. Despite this, Kann noted that the loss of Akorn Pharmaceuticals may lead to drug shortages if other generic manufacturers cannot meet the needs of the consumers who were previously treated with medications prepared by Akorn. Akorn products were distributed nationwide to wholesalers, retailers, manufacturers, medical facilities, repackagers, and consumers online.
ACORN PHARMACY
Over the last decade, the number of generic drugs made in the U.S. has dwindled. The only year that number did not fall was 2014, according to the report. Our mission is to provide an environment where patients receive the best health care and human care possible.
We do this by listening to our patients’ needs and presenting them with the best options for overall health and wellness. We strive to recommend safe and reliable nutritional/lifestyle interventions as part of a comprehensive, integrative medical practice. At Achorn Pharmacy & Fine Cosmetics we specialize in a wide range of beauty and health care products. Akorn is notifying its distributors and direct consignees by direct mailing and is requesting they further notify their customers/consumers/retailers. Consumers/distributors/retailers that have products which are being recalled should discard and contact their doctor. Global Pharma, also based in India, recalled its EzriCare Artificial Tears eye drops this year after the products were linked to highly drug-resistant bacterial infections that resulted in four deaths.