FDA Recall D-0830-2021
DuPont Nutrition USA, Inc · Newark, DE
Class I — life-threatening Terminated 196 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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).
Recall record
- Recall number
D-0830-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- 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.
- Recall initiated
- 2021-08-27
- Classified by FDA Center
- 2021-09-23
- FDA published
- 2021-09-29
- Terminated
- 2022-03-11
- Recalling firm
- DuPont Nutrition USA, Inc
- Firm location
- Newark, DE