The Recall Desk

FDA (Drugs) recall action 91616

DuPont Nutrition USA, Inc recalled 4 products on 2023-03-08

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
2023-03-08
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)··2023-03-08

    Microcrystalline Cellulose Pharmaceutical Excipient Recalled for Specification Failure

    DuPont Nutrition USA is recalling BD-102 NF Microcrystalline Cellulose, a pharmaceutical excipient, due to failed conductivity specifications. Affected batches were distributed nationwide and internationally for use in drug manufacturing.

    Product
    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: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen,
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2023-03-08

    DuPont Avicel PH-102 Microcrystalline Cellulose Recalled for Conductivity Specification Failure

    DuPont Nutrition USA is recalling Avicel PH-102 NF microcrystalline cellulose excipient due to failed conductivity specifications indicating potential impurities. The product was distributed nationwide and internationally.

    Product
    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. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Cope
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2023-03-08

    Microcrystalline Cellulose Ingredient Recalled Over Failed Impurity Specifications

    DuPont Nutrition USA, Inc. is recalling certain batches of Avicel PH-101 microcrystalline cellulose because it failed quality testing for impurities and degradation. The ingredient showed out-of-specification conductivity levels.

    Product
    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. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Cope
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2023-03-08

    Avicel PH-200 pharmaceutical excipient recalled for failed conductivity specification

    DuPont is recalling Avicel PH-200, a pharmaceutical excipient, because test results showed conductivity out of specification. No illnesses or injuries have been reported.

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