Class II · Moderate risk
Rufinamide Tablets
cGMP deviations: Batch was released prior to approval.
FDA Drug Recalls
207 recalls, newest first
Class II · Moderate risk
Cromolyn Sodium Oral Solution
CGMP deviation: product released prior to supplier 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
Dry Eye Relief Lubricant Eye Drops
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Class II · Moderate risk
Original Eye Drops
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
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
Class II · Moderate risk
SnoreStop Naso Spray Bulk
cGMP deviations
Class II · Moderate risk
DoloEar Earache Drops
cGMP deviations
Class II · Moderate risk
Babelyn Diarrhea Drops Homeopathic Remedy
cGMP deviations
Class II · Moderate risk
Bebelyn Colic Drops Homeopathic Remedy
cGMP deviations
Class II · Moderate risk
Arnica 7 Cream
cGMP deviations
Class II · Moderate risk
Kanjo Homeopathic Pain Relief Cream With Arnica
cGMP deviations
Class II · Moderate risk
Levsin injection
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk
Foaming Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.