Class II · Moderate risk
Helix Tri-Active Therapy Cream
CGMP Deviations
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Helix Pain Relieving Cream
CGMP Deviations
Class II · Moderate risk
Protex Foaming Hand Sanitizer
CGMP Deviations
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 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
Class II · Moderate risk
fentaNYL 1.5 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
PHENYLephrine 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
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
fentaNYL in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles