Drug 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
D-0830-2021
Product summary
- Event
- Event 88617
- Status
- Terminated
- Classification
- Class I
- Quantity
- 80 kg
- Official record key
drug-enforcement:D-0830-2021
Official wording
Reason: Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
Code information: Lot # 2173766940
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.
Derived failure modes
-
Microbial contamination
Microbial Contamination
-
Potency or specification failure
Out-of-specification