Class III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
FDA Drug Recalls
1,018 recalls, newest first
Class III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class I · High risk
Morphine Sulfate extended-Release Tablets
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
Morphine Sulfate extended-Release Tablets
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
Draximage MAA
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Class II · Moderate risk
Eszopiclone Tablets
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Class III · Low risk
Mometasone Furoate
Defective Container
Class II · Moderate risk
70% ISOPROPYL ALCOHOL First aid antiseptic
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
Tretinoin Capsules
Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Class I · High risk
CVS Health Magnesium Citrate SALINE LAXATIVE
Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens
Class II · Moderate risk
Fluticasone Propionate Nasal Spray
Defective container: defect prevents product from dispensing as intended.
Class I · High risk
Arti King Refozado con Ortiga y Omega 3 Tablets
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone.
Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Boric Acid 600 mg per suppository
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Boric Acid 600 mg capsules
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Doxycycline
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Bethanechol Chloride 1mg/ml
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Calcipotriene Topical Solution
Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
Class II · Moderate risk
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Testosterone Cypionate Injection
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Class II · Moderate risk
Zileuton Extended-Release Tablets
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Class I · High risk
SnoreStop NasoSpray
Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.
Class II · Moderate risk
Clonidine Transdermal System
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Class I · High risk
Allergy Bee Gone for Kids Nasal Swab Remedy 0.33 FL OZ
Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain elevated levels of yeast and mold as well as the presence of Bacillus cereus.