Class I - Dangerous
Lack of Assurance of Sterility: Leaking/damaged syringes.
Denver Solutions, LLC
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class I - Dangerous
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class I - Dangerous
Lack of Assurance of Sterility: Leaking/damaged syringes.
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class I - Dangerous
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class I - Dangerous
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class I - Dangerous
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I - Dangerous
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I - Dangerous
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I - Dangerous
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I - Dangerous
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I - Dangerous
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I - Dangerous
Labeling: Not Elsewhere Classified
Class I - Dangerous
Labeling: Not Elsewhere Classified
Labeling: Not Elsewhere Classified
Class I - Dangerous
CGMP DEVIATIONS
Class I - Dangerous
CGMP DEVIATIONS
Class I - Dangerous
CGMP DEVIATIONS
Class I - Dangerous
CGMP DEVIATIONS
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL