Class II · Moderate risk
Diazepam Injection USP 10mg/2mL
Crystallization: Product contains particulate identified to be crystallized active ingredient.
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.
14,543 recalls, newest first.
Class II · Moderate risk
Albuterol Sulfate Syrup
Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
Class II · Moderate risk
Alprazolam Extended-release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class II · Moderate risk
Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class II · Moderate risk
Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class II · Moderate risk
Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class II · Moderate risk
Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class II · Moderate risk
Ondansetron Injection USP 40 mg/20 mL
CGMP Deviations
Class II · Moderate risk
Eptifibatide Injection 75 mg/100 mL
CGMP Deviations
Class II · Moderate risk
Linezolid Injection 600 mg/300 mL Rx Only
CGMP Deviations
Class II · Moderate risk
ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL
CGMP Deviations
Class II · Moderate risk
Oxacillin for Injection
Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
Class II · Moderate risk
Chlorhexidine Gluco. 0.12% Oral Rinse
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
Class II · Moderate risk
Nitrofurantoin Oral Suspension
Failed Dissolution Specifications
Class II · Moderate risk
Itraconazole 0.2%/Mupirocin 0.2%/Triamcinolone 0.03% Nasal Spray
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Itraconazole 0.2%/Mupirocin 0.2% Nasal Spray
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Clotrimazole 1%/ Betamethasone Dipropionate 0.05% Otic Solution
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Quad-Mix #3
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Vitamin B Complex # 3
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Vitamin B Complex # 1
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Vancomycin 50mg/Ml Ophth Solution
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Tri-Mix # 6
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Tri-Mix # 5
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Tri-Mix # 4
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.