Avicel RC-591 NF NF recalled over sterility concerns

Recall date

August 27, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

DuPont Nutrition USA, Inc recalls Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition U…

Recall number

D-0830-2021

FDA classification

Class I

Brand / firm

DuPont Nutrition USA, Inc

Sold / distributed

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.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What 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