Overview of recall records associated with Fresenius Kabi USA, LLC, including dates, categories and classifications where available.
Classification mix: Class II: 50, Class I: 26, Class III: 6.
CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl…
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Subpotent; 18 month time point
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
Subpotent Drug; 15-month stability test station
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials
This page summarizes recall records in which the official source identifies Fresenius Kabi USA, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
