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All product recalls associated with Fagron, Inc.
Total Recalls
22
Past Year
0
Class I (Serious)
1
Most Recent
Dec 2023
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Microbial contamination of non-sterile product.
Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
cGMP Deviations: lack of quality assurance at the API manufacturer.
Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
cGMP Deviations: lack of quality assurance at the API manufacturer.
cGMP Deviations: lack of quality assurance at the API manufacturer.
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.