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All product recalls associated with Eugia US LLC.
Total Recalls
15
Past Year
4
Class I (Serious)
1
Most Recent
May 2025
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.
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
CGMP Deviations
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Failed Dissolution Specifications
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Presence of Particulate Matter
Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial