D-0545-2023 Class III Terminated
FDA drug recall D-0545-2023 was initiated by DuPont Nutrition USA, Inc on Apr 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 Mar 4, 2024). Affected quantity: 320,350 kg in bulk drums, boxes & sacks.
Recall details
- Product Type
- Drugs
- Report Date
- May 3, 2023
- Initiation Date
- Apr 13, 2023
- Termination Date
- Mar 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 320,350 kg in bulk drums, boxes & sacks
Product description
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.
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: P220834360, P220834366, P220834383, P220834440, P220834460, 2173755143, 2173771316, 2173773188, P220834401, P220834403, P220834482, P220834505, P220834543, P220834545
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0545-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026