Class II · Moderate risk Terminated
Sunitinib Malate Capsules
Reason Failed Moisture Limits: Water (moisture) content above the approved product specifications.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Bivalirudin for Injection 250 mg
Reason Presence of Particulate Matter: Particulate matter identified as fiber.
Class II · Moderate risk Terminated
Atropine Sulfate Injection
Reason Presence of Particulate Matter: Particulate matter identified as fiber.
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Class II · Moderate risk Ongoing
Tizanidine Hydrochloride Tablet 4mg
Reason Failed Stability Specifications
Class II · Moderate risk Terminated
Safe Tussin PM Night Time Cough Relief
Reason CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk Terminated
Safe Tussin DM Cough + Chest Congestion
Reason CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk Terminated
Tizanidine Tablets
Reason 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 Ongoing
Diclofenac Sodium Topical Solution USP
Reason Defective Delivery System
Class II · Moderate risk Ongoing
Tizanidine Tablets USP
Reason Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Class II · Moderate risk Terminated
Tramadol Hydrochloride Tablets
Reason Packaging defect: blister packaging inadequately sealed.
Class II · Moderate risk Ongoing
Dry Eye Relief Lubricant Eye Drops
Reason CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Class II · Moderate risk Ongoing
Original Eye Drops
Reason CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Class II · Moderate risk Terminated
Endometrin
Reason cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
StellaLife VEGA Oral Care Gel
Reason cGMP deviations
Class II · Moderate risk Terminated
StellaLife VEGA Oral Care Gel
Reason cGMP deviations
Class II · Moderate risk Terminated
StellaLife VEGA Oral Care Spray
Reason cGMP deviations
Class II · Moderate risk Terminated
StellaLife VEGA Oral Care Rinse
Reason cGMP deviations
Class II · Moderate risk Terminated
StellaLife VEGA Oral Care Rinse
Reason cGMP deviations
Class II · Moderate risk Terminated
SnoreStop Naso Spray Bulk
Reason cGMP deviations
Class II · Moderate risk Terminated
DoloEar Earache Drops
Reason cGMP deviations
Class II · Moderate risk Terminated
Babelyn Diarrhea Drops Homeopathic Remedy
Reason cGMP deviations
Class II · Moderate risk Terminated
Bebelyn Colic Drops Homeopathic Remedy
Reason cGMP deviations
Class II · Moderate risk Terminated
Arnica 7 Cream
Reason cGMP deviations
Class II · Moderate risk Terminated
Kanjo Homeopathic Pain Relief Cream With Arnica
Reason cGMP deviations