Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition U
Summary
The FDA issued a Class III for Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 by DuPont Nutrition USA, Inc. Reason: Out of specification results for conductivity..
Details
Source
Drug Recall
External ID
D-0728-2021
Action Date
2021-08-25
Status
Terminated
Category
drug
Product Description
Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
Lot/Code Info: Lot Numbers: P120834253, PN20834314, PN20834326, P220834329, P120834471, 2173728724, 2173731307, 2173739294, 2173742956, 2173743721, 2173747040 217374970, 2173749846, 2173751395, 2173751995, 2173753080, 2173749460, 2173755135, 2173755142, 2173758869, 22173758869 2173759101, 2173759087, 2173760958, 21737606959, 2173762248, 217376233, 2173763871 2173763872, 2173755139, 2173763875, 2173764734, 2173763870, 2173764735, 2173769670, 2173775381, 2173776518, 217377536, 2173779284, 2173800414, 2173801736, 2173801737, 2173802516, 2173805796, 2173805797, 2173806449, 2173806450, 2173809474, 2173809473 2173810873, 2173811314, 2173811315, 2173806441, 217381169, 2173811666 These excipients are noted not to have an expiration date.
Quantity Affected: 2,384,720 kg
Reason for Recall
Out of specification results for conductivity.
Distribution
Product was distributed nationwide, including Puerto Rico and to foreign accounts abroad.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-05
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 55 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-0728-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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