Class II · Moderate risk
TPC Drops
Lack of Assurance of Sterility
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
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Cefuroxime 4mg /0.4 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin in Balanced Salt Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Tropi-Phen
Lack of Assurance of Sterility
Class II · Moderate risk
Calcium Gluconate 2.5% solution for inhalation
Lack of Assurance of Sterility
Class II · Moderate risk
Calcium Gluconate Ophthalmic Irrigation Solution 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Endophth Kit
Lack of Assurance of Sterility
Class II · Moderate risk
Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Bevacizumab 1.25 MG/0.05 ML Solution for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Restore Sinus Spray
Microbial contamination of Non-Sterile Products
Class II · Moderate risk
ION* Sinus Support Nasal Spray
Microbial contamination of Non-Sterile Products
Class II · Moderate risk
Gynazole-1
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Class II · Moderate risk
Triamcinolone Acetonide Injectable Suspension
Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
Class II · Moderate risk
Oxybutynin Chloride Extended-Release Tablets USP 10 mg
Failed Dissolution Specifications
Class II · Moderate risk
HYDROmorphone in dextrose 5%
Lack of assurance of sterility:
Class II · Moderate risk
HYDROmorphone in 0.9% Sodium Chloride
Lack of assurance of sterility:
Class II · Moderate risk
HYDROmorphone in dextrose 5%
Lack of assurance of sterility:
Class II · Moderate risk
HYDROmorphone in 0.9% sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
HYDROmorphone in 0.9% sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
HYDROmorphone in 0.9% sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
succinylcholine
Lack of assurance of sterility:
Class II · Moderate risk
fentaNYL
Lack of assurance of sterility:
Class II · Moderate risk
fentaNYL in dextrose 5%
Lack of assurance of sterility: