Class II · Moderate risk
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Class II · Moderate risk
Walgreens
Chemical Contamination: Presence of benzene
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk
Neupogen (filgrastim)
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Class II · Moderate risk
Neupogen (filgrastim)
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Class II · Moderate risk
Metformin Hydrochloride Extended- Release 500mg
Presence of Foreign Tablets/Capsules.
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications - low dissolution results
Class II · Moderate risk
Zapzyt
Chemical Contamination: Presence of benzene.
Class II · Moderate risk
Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe
Lack of Assurance of Sterility: due to a quality control process deviation
Class II · Moderate risk
CURAD Alcohol Prep Pads
Subpotent Drug
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 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.