DuPont Nutrition USA, Inc. has voluntarily recalled approximately 2.38 million kilograms of Avicel Microcrystalline Cellulose, an excipient used in drug manufacturing, packaged in bulk as PH101 NF, PH102 NF, and PH200 NF. The recall was initiated because testing showed out-of-specification results for conductivity, meaning the product did not meet the required electrical resistance standards for its chemical composition. These products were distributed nationwide, in Puerto Rico, and to international accounts.
Incorrect conductivity levels in drug excipients can indicate the presence of unintended ionic impurities or incorrect chemical properties, which may affect the stability or performance of the final medication. While this is a low-risk recall, the chemical specifications must be maintained to ensure the quality and consistency of the drug products being manufactured.
Drug excipient refund and guidance
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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