Class II · Moderate risk Terminated
Hydrogen Peroxide Topical Solution USP
Reason Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Launch Sequence Aphrodisia Capsules
Reason Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class II · Moderate risk Terminated
Launch Sequence Euphoria Capsules
Reason Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class II · Moderate risk Terminated
Launch Sequence Capsules
Reason Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class II · Moderate risk Terminated
Divalproex Sodium Delayed-Release Tablets
Reason Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Class II · Moderate risk Terminated
Hydrogen Peroxide Topical Solution
Reason Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and back of the containers. However, the product inside the bottle is 70% Isopropyl Alcohol.
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason cGMP - Water leakage
Class II · Moderate risk Terminated
Draximage MAA
Reason Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Class II · Moderate risk Terminated
Eszopiclone Tablets
Reason Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Class II · Moderate risk Terminated
70% ISOPROPYL ALCOHOL First aid antiseptic
Reason Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.
Class II · Moderate risk Terminated
Tretinoin Capsules
Reason Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Class II · Moderate risk Terminated
Fluticasone Propionate Nasal Spray
Reason Defective container: defect prevents product from dispensing as intended.
Class II · Moderate risk Terminated
Estriol 1mg/gm
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk Terminated
Estriol 1mg/gm
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk Terminated
Boric Acid 600 mg per suppository
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk Terminated
Boric Acid 600 mg capsules
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk Terminated
Doxycycline
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk Terminated
Bethanechol Chloride 1mg/ml
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk Terminated
Calcipotriene Topical Solution
Reason Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
Class II · Moderate risk Terminated
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Class II · Moderate risk Terminated
Zileuton Extended-Release Tablets
Reason Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Class II · Moderate risk Terminated
Clonidine Transdermal System
Reason Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Class II · Moderate risk Terminated
CORRECTDOSE Children's COUGH & CHEST CONGESTION DM
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk Terminated
CORRECTDOSE Children's PAIN RELIEF & Fever Reducer
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.