Avicel RC-591 NF Bulk Powder Recalled for Microbial Contamination
DuPont Nutrition USA is recalling Avicel RC-591 NF bulk powder (lot #2173766940) due to out-of-specification microbial contamination. The product was distributed as a component in finished drug formulations nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I by the issuing agency. Per the severity rubric, FDA Class I recalls with microbial contamination of a drug ingredient warrant a minimum score of 4 (Severe), even absent reported illnesses, because of the risk of harm to patients who may receive contaminated drug products.
Plain-English summary
DuPont Nutrition USA, Inc. is recalling Avicel RC-591 NF (a microcrystalline cellulose and carboxymethylcellulose sodium blend) supplied in 80 kg drums. The recall was initiated because the product failed microbial testing, with total aerobic microbial count (TAMC) results exceeding specifications.
The affected lot (#2173766940) was distributed to one account that may have incorporated it as a component into finished drug formulations, which were then distributed nationwide in the United States.
Consumers and healthcare providers who have received drug products containing this ingredient should contact the recalling firm or their healthcare provider for further guidance. The source text does not specify actions such as product returns or destruction procedures.
The recalled product
- 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
- Manufacturer
- DuPont Nutrition USA, Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 2173766940
Distribution
Distributed nationwide across the United States.
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