D-0350-2023 Class III Terminated
FDA drug recall D-0350-2023 was initiated by DuPont Nutrition USA, Inc on Feb 1, 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 Dec 20, 2023). Affected quantity: 368,980 kg polyethylene lined fiber drums, boxes & sacks.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 8, 2023
- Initiation Date
- Feb 1, 2023
- Termination Date
- Dec 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 368,980 kg polyethylene lined fiber drums, boxes & sacks
Product description
Avicel PH- 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 pattern
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
Code information
Batch # 2173747038, 2173773188, 2173777535, P220834401, P220834402, P220834404, P220834406, P220834422, P220834425, P220834429, P220834430, P220834482, P220834505, P220834508, P220834543, These excipients are noted not to have an expiration date.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0350-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026