Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk contain
Summary
The FDA issued a Class III for Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gro by DuPont Nutrition USA, Inc. Reason: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity..
Details
Source
Drug Recall
External ID
D-0350-2023
Action Date
2023-03-08
Status
Terminated
Category
drug
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
Lot/Code Info: 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.
Quantity Affected: 368,980 kg polyethylene lined fiber drums, boxes & sacks
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-01
Company
Newark, DE
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 123 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
DuPont Nutrition USA, Inc has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DuPont Nutrition USA, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DuPont Nutrition USA, Inc have FDA actions?
DuPont Nutrition USA, Inc has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0350-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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