Class I · High risk
4.2% Sodium Bicarbonate Injection
Presence of Particulate Matter: identified as glass.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Foscarnet Sodium 2.4mg/0.1 mL solution for injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration
Lack of Assurance of Sterility
Class II · Moderate risk
Tropi-Phen
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl 4% ophthalmic solution
Lack of Assurance of Sterility
Class II · Moderate risk
Calcium chloride Solution for Intravenous Injection
Lack of Assurance of Sterility
Class II · Moderate risk
TPC Drops
Lack of Assurance of Sterility
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 I · High risk
ION*Sinus 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 I · High risk
Brexafemme
Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
Class III · Low risk
Methotrexate Tablets
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
Class II · Moderate risk
Oxybutynin Chloride Extended-Release Tablets USP 10 mg
Failed Dissolution Specifications