Class II · Moderate risk
biotene PBF Toothpaste
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
FDA Drug Recalls
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Class II · Moderate risk
biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
biotene Gentle Mint Gel
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class III · Low risk
Phentermine Hydrochloride Capsules
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Class III · Low risk
Mometasone Furoate Ointment USP
Subpotent drug
Class III · Low risk
Intermezzo
Failed dissolution specifications
Class II · Moderate risk
Clonidine Hydrochloride Tablets
cGMP Deviations
Class II · Moderate risk
Clonidine Hydrochloride Tablets
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
Clonidine Hydrochloride Tablets
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
Clonidine Hydrochloride Tablets
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
Nitroglycerin Transdermal System 0.4 mg/hr
Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
Class II · Moderate risk
Nitroglycerin Transdermal System 0.2 mg/hr
Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.
Class III · Low risk
Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme…
Subpotent Drug: menthol and methyl salicylate below specification
Class III · Low risk
Cvs Sugar Free Black Cherry Cough Drops
Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops.
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
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
0.9% Sodium Chloride Injection USP
Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
Class III · Low risk
Panadol (acetaminophen)
Failed Dissolution Specifications
Class II · Moderate risk
Capecitabine Tablets
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
Class III · Low risk
HydrOXYzine Hydrochloride Tablets
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Class III · Low risk
Metoclopramide Oral Solution
Defective Container: Lids on unit dose cups are not fully qualified.
Class II · Moderate risk
S-Methylcobalamin 5000 mcg/mL Inj.
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
SIH-Hydroxyprogesterone Caproate 250
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
SIU-Phentolamine 5 mg/mL in Normal Saline
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
SIU-Prostaglandin E1 500 mcg/mL Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.