Class II · Moderate risk
EPINEPHrine added to dextrose 5%
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
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Class II · Moderate risk
EPINEPHrine
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Cardioplegia Solution del Nido Formula
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
EPINEPHrine 4mg/250mL added to 0.9% sodium chloride
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
dilTIAZem 125mg/125mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
glycopyrrolate 1 mg/5 mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
dilTIAZem 125mg/125mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
vancomycin 1.25 g/250 mL added to dextrose 5%
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
succinylcholine 200 mg/10 mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
vancomycin 1 g/250 mL added to 0.9% sodium chloride
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
rocuronium50 mg/5 mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Methylphenidate Hydrochloride Tablets
Presence of Foreign Substance: Metal embedded in a tablet.
Class II · Moderate risk
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II · Moderate risk
ROcuronium Bromide 50 mg/5 mL
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II · Moderate risk
PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II · Moderate risk
SUCCINYLcholine Chloride 200 mg/10mL
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II · Moderate risk
Tiagabine Hydrochloride Tablets
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Class II · Moderate risk
Norepinephrine 32 mg per 250 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine 16 mg per 250 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine 8 mg per 250 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine 4 mg per 250 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Bicarbonate in 5% Dextrose Injection
Lack of Assurance of Sterility
Class III · Low risk
Loteprednol Etabonate Ophthalmic Suspension
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of assurance of sterility: bags have the potential to leak.