DuPont Nutrition USA, Inc. has recalled 614,340 kg of Avicel and BD-102 NF microcrystalline cellulose due to potential impurity issues. These products are excipients—bulk ingredients used in the manufacturing of various medications—and were distributed in bulk polyethylene-lined fiber drums, boxes, and sacks. Testing showed that conductivity levels were outside of the required specifications, which indicates that these materials did not meet strict pharmaceutical purity standards. No injuries or incidents have been reported in connection with this recall.
Impurities identified by failed conductivity tests could compromise the quality or chemical stability of drugs produced using these ingredients. While the risk to final consumers is considered low, the material failed to meet the required quality specifications for degradation and impurities.
Distributed in polyethylene lined fiber drums, boxes & sacks. Excipients do not have an expiration date.
Distributed in polyethylene lined fiber drums, boxes & sacks. Excipients do not have an expiration date.
Distributed in polyethylene lined fiber drums, boxes & sacks. Excipients do not have an expiration date.
Distributed in polyethylene lined fiber drums, boxes & sacks. Excipients do not have an expiration date.
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Sources: FDA iRES · Raw API Response
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