August 2021 FDA Recall Drug by Dupont Nutrition Usa, Inc
D-0830-2021 - Microbial Contamination of Non-Sterile Product

This Class I drug recall was voluntarily initiated by Dupont Nutrition Usa, Inc on August 27, 2021 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile product. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0830-2021

Reason for Recall
Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
Initiated
08-27-2021
Reported
09-29-2021
Quantity
80 kg

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88617
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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 to one account that may have used it as a component in finished drug formulations, and further distributed Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-11-2022
Product Description About Product Description
Full technical description of the product.
Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711

Batch or Lot Expiration Information

Lot# 2173766940