Class II · Moderate risk Ongoing
CURAD Alcohol Prep Pads
Reason Subpotent Drug
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Medline Alcohol Prep Pads
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II · Moderate risk Ongoing
Lorazepam 0.5 mg per 0.25 mL Oral Syringe
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II · Moderate risk Ongoing
Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II · Moderate risk Ongoing
Simethicone 20 mg per 0.3 mL Oral Syringe
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II · Moderate risk Ongoing
Ergocalciferol - Vitamin D Supplement - 10 mcg
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II · Moderate risk Ongoing
Iodo Blanco Iodides
Reason Defective Container: broken or leaking bottles.
Class II · Moderate risk Ongoing
Kids by babyganics SPF 50 mineral sunscreen totally tropical
Reason Chemical Contamination
Class II · Moderate risk Ongoing
Kids by babyganics SPF 50 totally tropical
Reason Chemical Contamination
Class II · Moderate risk Ongoing
Nelarabine Injection
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Nelarabine Injection
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
ViaMed Alcohol Prep Pads
Reason Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Class II · Moderate risk Terminated
Sodium Chloride Injection 9%
Reason Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Class II · Moderate risk Ongoing
Voriconazole Container Description: voriconazole The product…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Chlorambucil Container Description: The product packed in double…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Finasteride NDC# 82187-1003-1 Container Description: The product…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Alprostadil Container Description: Amber color bottle
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Bimatoprost NDC# 82187-1001-1 Container description: The…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Morphine Sulfate Extended-Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Completed
Estradiol Gel
Reason Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Class II · Moderate risk Ongoing
Silodosin Capsules
Reason 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 Ongoing
Ciprofloxacin Ophth Solution
Reason 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 Completed
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL
Reason Lack of Assurance of Sterility