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Recall Observatory FDA recall evidence

Drug product

Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark.

D-0545-2023

April 13, 2023

Class III

Product summary

Firm
DuPont Nutrition USA, Inc
Event
Event 92120
Status
Terminated
Classification
Class III
Quantity
320,350 kg in bulk drums, boxes & sacks
Official record key
drug-enforcement:D-0545-2023

Official wording

Reason: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

Code information: Batch Numbers: P220834360, P220834366, P220834383, P220834440, P220834460, 2173755143, 2173771316, 2173773188, P220834401, P220834403, P220834482, P220834505, P220834543, P220834545

Distribution pattern: Nationwide in the USA, Malta, Canada, China, Peru, Mexico, Australia, Saudi Arabia, Spain, Dominican Republic, Puerto Rico, Singapore, Bangkok, Ireland, India, and Columbia.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification