Class II · Moderate risk
Sunitinib Malate Capsules
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
FDA Drug Recalls
775 recalls, newest first
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 I · High risk
Albuterol Sulfate Inhalation Aerosol
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Class III · Low risk
Amlodipine Besylate Tablets
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Class II · Moderate risk
Losartan Potassium Tablets
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Class I · High risk
Tydemy
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
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 III · Low risk
Lysteda (tranexamic acid)
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Glycopyrrolate Injection
Labeling: Label Mix-up
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