August 2021 FDA Recall Drug by Dupont Nutrition Usa, Inc
D-0728-2021 - Out of specification results for conductivity.

This Class III drug recall was voluntarily initiated by Dupont Nutrition Usa, Inc on August 5, 2021 for the product Drug. The FDA reported the reason for recall as out of specification results for conductivity.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0728-2021

Reason for Recall
Out of specification results for conductivity.
Initiated
08-05-2021
Reported
08-25-2021
Quantity
2,384,720 kg

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88428
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
DuPont Nutrition USA, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed nationwide, including Puerto Rico and to foreign accounts abroad.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-07-2023
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# 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.