Class II · Moderate risk Terminated
dilTIAZem 125mg/125mL
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
glycopyrrolate 1 mg/5 mL
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk Terminated
dilTIAZem 125mg/125mL
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk Terminated
vancomycin 1.25 g/250 mL added to dextrose 5%
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk Terminated
succinylcholine 200 mg/10 mL
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk Terminated
vancomycin 1 g/250 mL added to 0.9% sodium chloride
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk Terminated
rocuronium50 mg/5 mL
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk Ongoing
Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Methylphenidate Hydrochloride Tablets
Reason Presence of Foreign Substance: Metal embedded in a tablet.
Class II · Moderate risk Ongoing
Oxacillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Oxacillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Oxacillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Fingolimod Capsules
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL
Reason CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II · Moderate risk Terminated
ROcuronium Bromide 50 mg/5 mL
Reason CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II · Moderate risk Terminated
PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL
Reason CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II · Moderate risk Terminated
SUCCINYLcholine Chloride 200 mg/10mL
Reason CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II · Moderate risk Ongoing
Big Machine Distillery Hand Sanitizer Non-Sterile Solution…
Reason CGMP Deviation: impurities exceed allowable limits.
Class II · Moderate risk Terminated
Tiagabine Hydrochloride Tablets
Reason Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Class II · Moderate risk Terminated
Norepinephrine 32 mg per 250 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine 16 mg per 250 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine 8 mg per 250 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine 4 mg per 250 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sodium Bicarbonate in 5% Dextrose Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP
Reason Lack of assurance of sterility: bags have the potential to leak.