Class II · Moderate risk
BioGlo Fluorescein Sodium Ophthalmic Strips USP
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
FDA Drug Recalls
140 recalls · Class II, newest first
Class II · Moderate risk
Bio Glo Fluorescein Sodium Ophthalmic Strips USP
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
CHNaO Fluorescein Sodium Ophthalmic Strips
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
Vista Gonio Eye Lubricant
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced…
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
Vista Gel Hypromellose USP 0.3% w/v
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
Vista Tears Polyethylene Glycol 400 0.4% w/v
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
0.9% SODIUM CHLORIDE Injection
Lack of Assurance of Sterility: Potential for flexible container leaks.
Class II · Moderate risk
Opdualag (nivolumab and relatlimab-rmbw)
Lack of Assurance of Sterility.
Class II · Moderate risk
Tirzepatide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HADLIMA (adalimumab-bwwd)
Lack of Assurance of Sterility.
Class II · Moderate risk
Fasenra (benralizumab)
Lack of Assurance of Sterility:
Class II · Moderate risk
Testo-100 Ciii
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Class II · Moderate risk
Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe
Lack of assurance of sterility.
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II · Moderate risk
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II · Moderate risk
bevacizumab
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride Irrigation USP. Isotonic Solution for Irrigation
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Class II · Moderate risk
Sterile Water for Injection USP
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.