Class II · Moderate risk
CURAD Alcohol Prep Pads
Subpotent Drug
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Medline Alcohol Prep Pads
Subpotent Drug
Class II · Moderate risk
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II · Moderate risk
Lorazepam 0.5 mg per 0.25 mL Oral Syringe
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
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.
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 I · High risk
BD ChloraPrep Clear 1mL Applicators
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
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 I · High risk
POTASSIUM CHLORIDE Inj.
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Class I · High risk
POTASSIUM CHLORIDE Inj.
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
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.