Home / Recalls / DuPont Nutrition USA, Inc / D-0830-2021

D-0830-2021 Class I Terminated

Recalled by DuPont Nutrition USA, Inc — Newark, DE

Recall Details

Product Type
Drugs
Report Date
September 29, 2021
Initiation Date
August 27, 2021
Termination Date
March 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

Other recalls by DuPont Nutrition USA, Inc

  • D-0544-2023 Class III — Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.0 K (April 13, 2023)
  • D-0546-2023 Class III — Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 K (April 13, 2023)
  • D-0547-2023 Class III — Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / 21. (April 13, 2023)
  • D-0545-2023 Class III — Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 K (April 13, 2023)
  • D-0349-2023 Class III — Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/Gro (February 1, 2023)
  • D-0350-2023 Class III — Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gro (February 1, 2023)
  • D-0351-2023 Class III — Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gros (February 1, 2023)
  • D-0352-2023 Class III — BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp., Net Content/Gross Weig (February 1, 2023)
  • D-0728-2021 Class III — Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 (August 5, 2021)