The Recall Desk

FDA (Drugs) recall action 92120

DuPont Nutrition USA, Inc recalled 4 products on 2023-05-03

The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2023-05-03
Critical
0
Units
—

Why these products were recalled

Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–4 of 4

  • ModerateFDA (Drugs)··2023-05-03

    DuPont Avicel PH-200 NF pharmaceutical ingredient recalled for conductivity specification failure

    DuPont is recalling Avicel PH-200 NF microcrystalline cellulose, a pharmaceutical ingredient, for failing conductivity specifications. The bulk ingredient was distributed to drug manufacturers in the USA and internationally.

    Product
    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; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1,
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2023-05-03

    DuPont Avicel DG pharmaceutical ingredient recalled for failed quality specification

    DuPont Nutrition USA is recalling Avicel DG, a pharmaceutical ingredient, due to failed quality specifications. The product did not meet conductivity standards during manufacturing testing.

    Product
    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; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenh
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2023-05-03

    DuPont Recalls Avicel PH-101 Microcrystalline Cellulose for Out-of-Specification Conductivity

    DuPont Nutrition USA is recalling specific batches of Avicel PH-101 NF microcrystalline cellulose due to failed conductivity specifications. The pharmaceutical excipient was distributed in bulk to manufacturers in the USA and multiple international locations.

    Product
    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; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1,
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2023-05-03

    FDA recalls Avicel PH-102 microcrystalline cellulose bulk ingredient for specification failure

    DuPont Nutrition is recalling Avicel PH-102 microcrystalline cellulose due to conductivity specification failures in 14 batches distributed across the USA and internationally.

    Product
    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; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1,
    Category
    Distribution
    1 state