FDA-Drug2021-09-29Class I

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

DuPont Nutrition USA, Inc
Hazard

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

Sold states
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.
Affected count
80 kg
Manufactured in
1301 Ogletown Rd, Newark, DE, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0830-2021

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