Class II · Moderate risk
Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
FDA Drug Recalls
676 recalls · Class II, newest first
Class II · Moderate risk
Simethicone 20 mg per 0.3 mL Oral Syringe
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II · Moderate risk
Ergocalciferol - Vitamin D Supplement - 10 mcg
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II · Moderate risk
Iodo Blanco Iodides
Defective Container: broken or leaking bottles.
Class II · Moderate risk
Kids by babyganics SPF 50 mineral sunscreen totally tropical
Chemical Contamination
Class II · Moderate risk
Kids by babyganics SPF 50 totally tropical
Chemical Contamination
Class II · Moderate risk
Nelarabine Injection
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Nelarabine Injection
Failed Impurities/Degradation Specifications
Class II · Moderate risk
ViaMed Alcohol Prep Pads
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Class II · Moderate risk
Sodium Chloride Injection 9%
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Class II · Moderate risk
Voriconazole Container Description: voriconazole The product…
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Alprostadil Container Description: Amber color bottle
CGMP Deviations
Class II · Moderate risk
Bimatoprost NDC# 82187-1001-1 Container description: The…
CGMP Deviations
Class II · Moderate risk
Morphine Sulfate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Estradiol Gel
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Class II · Moderate risk
Silodosin Capsules
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
Class II · Moderate risk
Ciprofloxacin Ophth Solution
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II · Moderate risk
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL
Lack of Assurance of Sterility
Class II · Moderate risk
Potassium Chloride Extended-Release Tablets
Failed Dissolution Specifications.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.