Edge Pharma, LLC Recalls Its Drug Products Due to Sterility Assurance Issues
Lack of Sterility Assurance Recall
According to an announcement from the U.S. Food and Drug Administration, Edge Pharma, LLC recalled its drug products due to sterility assurance issues. On December 4, 2021, Edge Pharma, LLC issued a letter to the FDA stating that processing issues may have caused a lack of sterility assurance for products intended to be sterile. Moreover, the manufacturing process problem may have impacted the quality and safety of non-sterile products at the consumer level.
According to the company’s recall risk statement, the defect could result cause serious systemic infections, which could be life-threatening.
The affected products include containers, syringes, IV bags, drop containers, bottles, vials, and jars. The affected lots and expiration dates are included may be found here. The recall is confined to all Edge Pharma, LLC compounded nonsterile and sterile and drug products within expiry. The affected products were distributed nationwide.
Purchasers who want more information or who have questions are asked to contact Edge Pharma, LLC. Patients are urged to talk to their doctor if they are experiencing any issues related to the recalled products.
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