DuPont Nutrition USA, Inc. has recalled 901,120 kilograms of Avicel Microcrystalline Cellulose products, including the PH-101, PH-102, PH-200, and Avicel DG varieties. These products, which are commonly used in the manufacture of pharmaceuticals and supplements, were found to have failed quality tests for conductivity. This failure indicates that the products did not meet required purity and degradation specifications. No injuries or adverse events have been reported in connection with this recall.
The failure to meet conductivity specifications suggests the material may contain unintended impurities or degradation products. While no incidents have occurred, using excipients that do not meet strict quality standards can affect the consistency, stability, or safety of the final medical products they are used to create.
Quantity: 464,050 kg in bulk drums, boxes & sacks
Quantity: 320,350 kg in bulk drums, boxes & sacks
Quantity: 93,660 kg in bulk drums, boxes & sacks
Quantity: 23,060 kg in bulk drums, boxes & sacks
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Sources: FDA iRES · Raw API Response
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