D-0546-2023 Class III Terminated
FDA drug recall D-0546-2023 was initiated by DuPont Nutrition USA, Inc on April 13, 2023 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. The recall status is terminated (terminated March 4, 2024). Affected quantity: 93,660 kg in bulk drums, boxes & sacks.
Recall Details
- Product Type
- Drugs
- Report Date
- May 3, 2023
- Initiation Date
- April 13, 2023
- Termination Date
- March 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 93,660 kg in bulk drums, boxes & sacks
Product Description
Avicel PH-200 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.
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
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.
Code Information
Batch Numbers: 2173766945, 2173768895, PN20834306, 217373201, PN20834301