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.
FDA drug recalls in 2023
Every FDA drug recall initiated in 2023, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,122 recalls, newest first.
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.
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.