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.
FDA Drug Recalls
18,003 recalls, newest first
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.
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
Big Machine Distillery Hand Sanitizer Non-Sterile Solution…
CGMP Deviation: impurities exceed allowable limits.
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.
Class II · Moderate risk
Sunitinib Malate Capsules
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Class II · Moderate risk
Bivalirudin for Injection 250 mg
Presence of Particulate Matter: Particulate matter identified as fiber.
Class II · Moderate risk
Atropine Sulfate Injection
Presence of Particulate Matter: Particulate matter identified as fiber.
Class I · High risk
Albuterol Sulfate Inhalation Aerosol
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).