Class II · Moderate risk
Montelukast Sodium Tablets
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Clinical TREAT Antifungal Powder
CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.
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 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: