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Fagron, Inc FDA Recalls

10 recalls on file across drugs, 1 of them Class I and 4 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, InClass IIDec 11, 2023Labeling: Label Error on Declared Strength: Assay value on t	Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.	Class IIDrugs	Dec 11, 2023
NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron,Class IIDec 11, 2023Labeling: Label Error on Declared Strength: Assay value on t	Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.	Class IIDrugs	Dec 11, 2023
NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, IClass IIDec 11, 2023Labeling: Label Error on Declared Strength: Assay value on t	Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.	Class IIDrugs	Dec 11, 2023
NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron,Class IIDec 11, 2023Labeling: Label Error on Declared Strength: Assay value on t	Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.	Class IIDrugs	Dec 11, 2023
Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 740Class IIIMar 4, 2022Subpotent Drug	Subpotent Drug	Class IIIDrugs	Mar 4, 2022
Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot KClass IIIMar 4, 2022Subpotent Drug	Subpotent Drug	Class IIIDrugs	Mar 4, 2022
Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot KClass IIIMar 4, 2022Subpotent Drug	Subpotent Drug	Class IIIDrugs	Mar 4, 2022
SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 515Class IMar 4, 2022Microbial Contamination of Non-Sterile Product: Product is c	Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.	Class IDrugs	Mar 4, 2022
Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 74Class IIIMar 4, 2022Subpotent Drug	Subpotent Drug	Class IIIDrugs	Mar 4, 2022
Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot KnClass IIIMar 4, 2022Subpotent Drug	Subpotent Drug	Class IIIDrugs	Mar 4, 2022

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