Class III · Low risk Ongoing
Pancreaze
Reason Failed Stability Specifications
FDA Drug Recalls
17,898 recalls, newest first
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 III · Low risk Ongoing
Tranexamic Acid USP Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class II · Moderate risk Terminated
Endometrin
Reason cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Class III · Low risk Terminated
Lysteda
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Terminated
Glycopyrrolate Injection
Reason Labeling: Label Mix-up
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
Class I · High risk Terminated
ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg
Reason Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.
Class II · Moderate risk Terminated
Amphotericin B Liposome for Injection
Reason Subpotent drug
Class II · Moderate risk Terminated
Extended Phenytoin Sodium Capsules
Reason Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)