FDA recall D-0352-2023

DuPont Nutrition USA, Inc · Class III · drug

Product

BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp., 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. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark

Reason for recall

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

Distribution

Product was distributed nationwide in the United States and Puerto Rico, and to Australia, China, Canada, Columbia, Mexico, Brazil, Malaysia, Chile, Dominic Republic, Singapore, Thailand, Ireland, Germany, South Korea, Argentina, Pakistan, Oman, India

Key facts

Status
Terminated
Initiation date
2023-02-01
Report date
2023-03-08
Termination date
2023-12-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Newark, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0352-2023