Class II · Moderate risk
Rasagiline Tablets 0.5mg
Failed dissolution specifications - results obtained were below spec average.
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Helix CBD Clinical Cream
CGMP Deviations
Class II · Moderate risk
Helix CBD Therapy Cream
CGMP Deviations
Class II · Moderate risk
Helix Tri-Active Therapy Cream
CGMP Deviations
Class II · Moderate risk
Helix Pain Relieving Cream
CGMP Deviations
Class II · Moderate risk
Protex Foaming Hand Sanitizer
CGMP Deviations
Class III · Low risk
0.9% Sodium Chloride Injection USP
Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
Class II · Moderate risk
Rufinamide Tablets
cGMP deviations: Batch was released prior to approval.
Class II · Moderate risk
Rufinamide Tablets
cGMP deviations: Batch was released prior to approval.
Class II · Moderate risk
FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag
cGMP deviations: due to shipment of rejected units.
Class III · Low risk
Fosfomycin Tromethamine Granules for Oral Solution
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Class III · Low risk
Dofetilide Capsules 500 mcg
Out of Specification result observed in content uniformity testing
Class II · Moderate risk
morphine in 0.9% Sodium Chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
fentaNYL in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
PHENYLephrine in 0.9 sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
PHENYLephrine in 0.9 sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
rocuronium
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
midazolam in dextrose 5%
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
lidocaine 2%
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
ePHEDrine in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium…
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
ketamine in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
morphine in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles