Class II · Moderate risk
Oxygen
cGMP Deviations
FDA Drug Recalls
152 recalls, newest first
Class III · Low risk
V-FORCE Homeopathic
Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
Class II · Moderate risk
Strong Iodine Solution U.S.P.
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Class II · Moderate risk
Integrity Biochem HSC 70-VA
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Class II · Moderate risk
Integrity Biochem HSC70-LV
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Class II · Moderate risk
Integrity Biochem HSC 70-LM
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
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 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
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
Safe Tussin PM Night Time Cough Relief
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk
Safe Tussin DM Cough + Chest Congestion
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk
StellaLife VEGA Oral Care Gel
cGMP deviations
Class II · Moderate risk
StellaLife VEGA Oral Care Gel
cGMP deviations
Class II · Moderate risk
StellaLife VEGA Oral Care Spray
cGMP deviations
Class II · Moderate risk
StellaLife VEGA Oral Care Rinse
cGMP deviations
Class II · Moderate risk
StellaLife VEGA Oral Care Rinse
cGMP deviations