Class II · Moderate risk Terminated
TPC Drops
Reason Lack of Assurance of Sterility
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cefuroxime 4mg /0.4 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Moxifloxacin in Balanced Salt Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Tropi-Phen
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Calcium Gluconate 2.5% solution for inhalation
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Calcium Gluconate Ophthalmic Irrigation Solution 1%
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Endophth Kit
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Bevacizumab 1.25 MG/0.05 ML Solution for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Restore Sinus Spray
Reason Microbial contamination of Non-Sterile Products
Class II · Moderate risk Terminated
ION* Sinus Support Nasal Spray
Reason Microbial contamination of Non-Sterile Products
Class I · High risk Terminated
ION*Sinus Spray
Reason Microbial contamination of Non-Sterile Products
Class II · Moderate risk Ongoing
Gynazole-1
Reason 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 Ongoing
Triamcinolone Acetonide Injectable Suspension
Reason 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 Completed
Brexafemme
Reason 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 Ongoing
Methotrexate Tablets
Reason 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 Terminated
Oxybutynin Chloride Extended-Release Tablets USP 10 mg
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
HYDROmorphone in dextrose 5%
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
HYDROmorphone in 0.9% Sodium Chloride
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
HYDROmorphone in dextrose 5%
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
HYDROmorphone in 0.9% sodium chloride
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
HYDROmorphone in 0.9% sodium chloride
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
HYDROmorphone in 0.9% sodium chloride
Reason Lack of assurance of sterility: