Recalls / Class I
Class ID-0830-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- Lot # 2173766940
Why it was recalled
Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
Recalling firm
- Firm
- DuPont Nutrition USA, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1301 Ogletown Rd, Newark, Delaware 19711-5419
Distribution
- Quantity
- 80 kg
- 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.
Timeline
- Recall initiated
- 2021-08-27
- FDA classified
- 2021-09-23
- Posted by FDA
- 2021-09-29
- Terminated
- 2022-03-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0830-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.