Fagron Gmbh

24 FDA enforcement records linked to this company.

• recall — Class II2023-12-27

  Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

• recall — Class II2023-12-27

  Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

• recall — Class II2023-12-27

  Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

• recall — Class II2023-12-27

  Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

• warning_letter2022-06-14

  FDA Warning Letter (drug product)

• recall — Class III2022-05-18

  Subpotent Drug

• recall — Class III2022-05-18

  Subpotent Drug

• recall — Class III2022-05-18

  Subpotent Drug

• recall — Class III2022-05-18

  Subpotent Drug

• recall — Class III2022-05-18

  Subpotent Drug

• recall — Class I2022-05-18

  Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.

• recall — Class II2019-12-11

  Microbial contamination of non-sterile product.

• warning_letter2018-08-29

  FDA Warning Letter (drug product)

• recall — Class II2018-03-07

  Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).

• recall — Class II2017-11-22

  cGMP Deviations: lack of quality assurance at the API manufacturer.