Class II · Moderate risk
phenylephrine 50 mg added to 0.9% sodium chloride 250mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Class II · Moderate risk
PHENYLephrine
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
phenylephrine
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
PHENYLephrine 20mg/250ml added to 0.9% sodium chloride
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
PHENYLephrine
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
EPINEPHrine 8mg/250ml added to dextrose 5%
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
EPINEPHrine added to dextrose 5%
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
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
Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil
Lack of Assurance of Sterility
Class II · Moderate risk
Methylphenidate Hydrochloride Tablets
Presence of Foreign Substance: Metal embedded in a tablet.
Class II · Moderate risk
Oxacillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Oxacillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Oxacillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Fingolimod Capsules
Failed Dissolution Specifications
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.