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.
Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
Defective container: Cracked vials leading to lack of sterility assurance
Low out of specification results for epinephrine assay.
Presence of Particulate Matter - found in reserve sample vials at the firm.
Presence of Particulate Matter - found in reserve sample vials at the firm.
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Cross Contamination with other products: trace amounts of lidocaine
Cross Contamination with Other Products: trace amounts of octreotide found during testing
Cross Contamination with other products: trace amounts of lidocaine
Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the…
Presence of Particulate Matter - found in reserve sample vials at the firm.
Presence of Particulate Matter - found in reserve sample vials at the firm.
Presence of Particulate Matter; glass particulates
Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers…
Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers…
Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain…
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
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.
