Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition US
Summary
The FDA issued a Class I for Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG dr by DuPont Nutrition USA, Inc. Reason: Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC)..
Details
Source
Drug Recall
External ID
D-0830-2021
Action Date
2021-09-29
Status
Terminated
Category
drug
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
Lot/Code Info: Lot # 2173766940
Quantity Affected: 80 kg
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-27
Company
Newark, DE
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 42 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
DuPont Nutrition USA, Inc has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DuPont Nutrition USA, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DuPont Nutrition USA, Inc have FDA actions?
DuPont Nutrition USA, Inc has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0830-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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