Class II · Moderate risk
ePHEDrine Sulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
ePHEDrine Sulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
ePHEDrine Sulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
Buffered Lidocaine
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
Buffered Lidocaine
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
atropine Sulfate Injection
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
atropine Sulfate Injection
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Felodipine Extended-Release Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Felodipine Extended-Release Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Felodipine Extended-Release Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class II · Moderate risk
Phenobarbital/Hyoscyamine/ Atropine/Scopolamine…
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
Class II · Moderate risk
Sensodyne With Fluoride Repair & Protect
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
Sensodyne Extra Fresh Repair & Protect
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
Sensodyne Complete Protection
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
Sensodyne Extra Fresh Complete Protection
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
biotene PBF Toothpaste
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 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