Eugia Us Llc

17 FDA enforcement records linked to this company.

• recall — Class III2026-06-10

  Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

• recall — Class II2025-06-25

  Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.

• recall — Class II2025-05-07

  Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

• recall — Class II2025-05-07

  Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

• recall — Class II2025-04-23

  cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

• recall — Class II2025-01-15

  Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.

• recall — Class II2025-01-15

  CGMP Deviations

• recall — Class II2024-08-07

  Presence of Particulate Matter: Complaint received of a glass particle in the vial.

• recall — Class III2024-06-26

  Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.

• recall — Class II2024-06-26

  Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.

• recall — Class I2024-04-17

  Presence of Particulate Matter

• recall — Class II2024-03-27

  Failed Impurities/Degradation Specifications: Out of specification for organic impurities

• recall — Class II2024-03-27

  Failed Impurities/Degradation Specifications: Out of specification for organic impurities

• recall — Class II2024-03-20

  Failed Stability Specification: Water determination was found not complying with specification.

• recall — Class II2024-03-13

  Failed Dissolution Specifications