FDA recall D-0544-2023

Product

Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.0 KG / 54.5 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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2023-04-13

Report date

2023-05-03

Termination date

2024-03-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Newark, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0544-2023