FDA recall D-0830-2021

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

Reason for recall

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

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.

Key facts

Status

Terminated

Initiation date

2021-08-27

Report date

2021-09-29

Termination date

2022-03-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Newark, DE, United States

Primary source

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