Class II · Moderate risk Terminated
Sensodyne With Fluoride Repair & Protect
Reason Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Sensodyne Extra Fresh Repair & Protect
Reason Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk Terminated
Sensodyne Complete Protection
Reason Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk Terminated
Sensodyne Extra Fresh Complete Protection
Reason Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk Terminated
biotene PBF Toothpaste
Reason Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk Terminated
biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT
Reason Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk Terminated
biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original
Reason Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk Terminated
biotene Gentle Mint Gel
Reason Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk Terminated
Clonidine Hydrochloride Tablets
Reason cGMP Deviations
Class II · Moderate risk Terminated
Clonidine Hydrochloride Tablets
Reason cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Class II · Moderate risk Terminated
Clonidine Hydrochloride Tablets
Reason cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Class II · Moderate risk Terminated
Clonidine Hydrochloride Tablets
Reason cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Class II · Moderate risk Terminated
Nitroglycerin Transdermal System 0.4 mg/hr
Reason Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
Class II · Moderate risk Terminated
Nitroglycerin Transdermal System 0.2 mg/hr
Reason Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP
Reason Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP
Reason Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
Class II · Moderate risk Terminated
Capecitabine Tablets
Reason Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
Class II · Moderate risk Terminated
S-Methylcobalamin 5000 mcg/mL Inj.
Reason Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk Terminated
SIH-Hydroxyprogesterone Caproate 250
Reason Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk Terminated
SIU-Phentolamine 5 mg/mL in Normal Saline
Reason Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk Terminated
SIU-Prostaglandin E1 500 mcg/mL Injection
Reason Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk Terminated
SO-Acetylcysteine 10% Sterile Ophthalmic Solution
Reason Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk Terminated
SIU-Tri-Mix 30/1/20 Injectable
Reason Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk Terminated
SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL
Reason Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk Terminated
SIU-Tri-Mix 30/2/20 Inj.
Reason Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.