Class II · Moderate risk
Sodium Bicarbonate in 5% Dextrose Injection
Lack of Assurance of Sterility
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of assurance of sterility: bags have the potential to leak.
Class II · Moderate risk
Sunitinib Malate Capsules
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Class II · Moderate risk
Bivalirudin for Injection 250 mg
Presence of Particulate Matter: Particulate matter identified as fiber.
Class II · Moderate risk
Atropine Sulfate Injection
Presence of Particulate Matter: Particulate matter identified as fiber.
Class II · Moderate risk
Losartan Potassium Tablets
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
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
Tizanidine Tablets
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Class II · Moderate risk
Tramadol Hydrochloride Tablets
Packaging defect: blister packaging inadequately sealed.
Class II · Moderate risk
Endometrin
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
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
Amphotericin B Liposome for Injection
Subpotent drug
Class II · Moderate risk
Extended Phenytoin Sodium Capsules
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Class II · Moderate risk
Travoprost Ophthalmic Solution
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.