D-0830-2021 Class I Terminated
FDA drug recall D-0830-2021 was initiated by DuPont Nutrition USA, Inc on Aug 27, 2021 and is designated Class I. Reason for recall: Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC). The recall status is terminated (terminated Mar 11, 2022). Affected quantity: 80 kg.
Recall details
- Product Type
- Drugs
- Report Date
- Sep 29, 2021
- Initiation Date
- Aug 27, 2021
- Termination Date
- Mar 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80 kg
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
Reason for recall
Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
Distribution pattern
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.
Code information
Lot # 2173766940
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0830-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026