Class I · High risk Terminated
Nifedipine WSP 0.2% Ointment
Reason Subpotent and Superpotent Drug
FDA Drug Recalls
14,801 recalls, newest first
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 III · Low risk Terminated
Esomeprazole Magnesium Delayed-Release Capsules
Reason Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class III · Low risk Terminated
Esomeprazole Magnesium Delayed-Release Capsules
Reason Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class I · High risk Terminated
Morphine Sulfate extended-Release Tablets
Reason Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Class I · High risk Terminated
Morphine Sulfate extended-Release Tablets
Reason Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
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 III · Low risk Terminated
Mometasone Furoate
Reason Defective Container
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 I · High risk Terminated
CVS Health Magnesium Citrate SALINE LAXATIVE
Reason Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens
Class II · Moderate risk Terminated
Fluticasone Propionate Nasal Spray
Reason Defective container: defect prevents product from dispensing as intended.
Class I · High risk Terminated
Arti King Refozado con Ortiga y Omega 3 Tablets
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone.
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.