Akorn Pharmaceutical Company, a leading generic pharmaceutical manufacturer, has issued a voluntary recall of more than 70 drugs due to concerns about the quality and purity of their products. This recall includes both prescription and over-the-counter medications and affects a wide range of therapeutic areas, including cardiovascular, ophthalmic, respiratory, and topical medications.
The recall was initiated after an inspection of the company’s manufacturing facility in Decatur, Illinois, by the US Food and Drug Administration (FDA). The inspection found significant violations of current good manufacturing practice (CGMP) regulations, including failures in the company’s quality control systems and inadequate testing of its products.
As a result of these findings, Akorn has suspended production at its Decatur facility and has started an investigation into the root causes of the issues identified by the FDA. The company has also implemented corrective and preventative actions to address the violations and prevent them from happening again in the future.
The recall affects products distributed in the United States and Canada, with the majority of the affected products being distributed in the US. The drugs being recalled include a range of commonly used medications, such as the antibiotic amoxicillin, the pain reliever acetaminophen, and the blood pressure medication losartan.
Patients who have been prescribed any of the affected medications should stop taking them immediately and contact their healthcare provider for guidance on alternative treatment options. The FDA has also advised patients to report any adverse events related to the use of these drugs to the agency’s MedWatch program.
The recall is expected to have a significant impact on the availability of generic medications in the US, as Akorn is a major supplier of these drugs. The company’s decision to suspend production at its Decatur facility will likely result in shortages of certain medications, particularly those that are in high demand.
This is not the first time that Akorn has faced issues with the quality of its products. In 2018, the company received a warning letter from the FDA regarding significant violations of CGMP regulations at its New Jersey manufacturing facility. The company’s stock price has also been in decline in recent years, with shares falling by more than 90% since 2017.
The FDA is closely monitoring the situation and working with Akorn to address the issues identified during the inspection. The agency has advised healthcare providers and patients to report any concerns or issues related to the quality of Akorn’s products to the FDA’s Center for Drug Evaluation and Research.
The recall is a reminder of the importance of ensuring the quality and safety of generic medications, which are an essential component of the healthcare system. Patients and healthcare providers should remain vigilant and report any concerns or issues related to the use of these drugs to the appropriate authorities.
