Newark, DE, United States
DuPont Nutrition USA, Inc recalls
4 recalls recorded since 2018, most recently on 13 April 2023. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)1
Terminated Class III Drugs
- Recall started
- 13 April 2023
- Terminated
- 4 March 2024
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Distribution
- Nationwide in the USA, Malta, Canada, China, Peru, Mexico, Australia, Saudi Arabia, Spain, Dominican Republic, Puerto Rico, Singapore, Bangkok, Ireland, India, and Columbia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0546-2023, D-0547-2023, D-0545-2023, D-0544-2023
- Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Hea
- Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarte
- Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Hea
- Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Hea
Terminated Class III Drugs
- Recall started
- 1 February 2023
- Terminated
- 20 December 2023
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Distribution
- Product was distributed nationwide in the United States and Puerto Rico, and to Australia, China, Canada, Columbia, Mexico, Brazil, Malaysia, Chile, Dominic Republic, Singapore, Thailand, Ireland, Germany, South Korea, Argentina, Pakistan, Oman, India
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0352-2023, D-0350-2023, D-0349-2023, D-0351-2023
- BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp., Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: D
- Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquar
- Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquar
- Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquart
Terminated Class I Drugs
- Recall started
- 27 August 2021
- Terminated
- 11 March 2022
- Reason
- Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0830-2021
- 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
Terminated Class III Drugs
- Recall started
- 5 August 2021
- Terminated
- 7 March 2023
- Reason
- Out of specification results for conductivity.
- Distribution
- Product was distributed nationwide, including Puerto Rico and to foreign accounts abroad.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0728-2021
- Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.