DuPont Nutrition USA, Inc: Drug Recall

Recall #D-0830-2021 · 08/27/2021

Class I: Dangerous

Recall Details

Recall Number
D-0830-2021
Classification
Class I
Product Type
Drug
Recalling Firm
DuPont Nutrition USA, Inc
Status
Terminated
Date Initiated
08/27/2021
Location
Newark, DE, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
80 kg

Reason for Recall

Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).

Product Description

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

Distribution Pattern

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.