PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: September 29, 2021 Initiated: August 27, 2021 #D-0830-2021

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

Reason for Recall

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

Details

Recalling Firm
DuPont Nutrition USA, Inc
Units Affected
80 kg
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.
Location
Newark, DE

Frequently Asked Questions

What product was recalled?
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. Recalled by DuPont Nutrition USA, Inc. Units affected: 80 kg.
Why was this product recalled?
Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
Which agency issued this recall?
This recall was issued by the FDA Drug on September 29, 2021. Severity: Critical. Recall number: D-0830-2021.