Class II · Moderate risk Terminated
Helix CBD Therapy Cream
Reason CGMP Deviations
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Helix Tri-Active Therapy Cream
Reason CGMP Deviations
Class II · Moderate risk Terminated
Helix Pain Relieving Cream
Reason CGMP Deviations
Class II · Moderate risk Terminated
Protex Foaming Hand Sanitizer
Reason CGMP Deviations
Class III · Low risk Terminated
0.9% Sodium Chloride Injection USP
Reason Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
Class III · Low risk Ongoing
Tobramycin Opthalmic Solution USP
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Rufinamide Tablets
Reason cGMP deviations: Batch was released prior to approval.
Class II · Moderate risk Terminated
Rufinamide Tablets
Reason cGMP deviations: Batch was released prior to approval.
Class II · Moderate risk Completed
Cromolyn Sodium Oral Solution
Reason CGMP deviation: product released prior to supplier approval.
Class II · Moderate risk Terminated
FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag
Reason cGMP deviations: due to shipment of rejected units.
Class III · Low risk Terminated
Fosfomycin Tromethamine Granules for Oral Solution
Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Class III · Low risk Terminated
Dofetilide Capsules 500 mcg
Reason Out of Specification result observed in content uniformity testing
Class II · Moderate risk Terminated
morphine in 0.9% Sodium Chloride
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
PHENYLephrine in 0.9 sodium chloride
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
PHENYLephrine in 0.9 sodium chloride
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
rocuronium
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
midazolam in dextrose 5%
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
lidocaine 2%
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
ePHEDrine in 0.9% sodium chloride
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium…
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
ketamine in 0.9% sodium chloride
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
morphine in 0.9% sodium chloride
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles