Class II · Moderate risk
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension
Lack of Assurance of Sterility
FDA Drug Recalls
2,357 recalls · Class II, newest first
Class II · Moderate risk
Klarity-C (cyclosporine)
Lack of Assurance of Sterility
Class II · Moderate risk
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL…
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials…
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use…
Lack of Assurance of Sterility
Class II · Moderate risk
Dexamethasone-Moxifloxacin- Ketorolac
Lack of Assurance of Sterility
Class II · Moderate risk
Dexamethasone-Moxifloxacin
Lack of Assurance of Sterility
Class II · Moderate risk
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL…
Lack of Assurance of Sterility
Class II · Moderate risk
Rizatriptan Benzoate Orally Disintegrating Tablets
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II · Moderate risk
Rizatriptan Benzoate Orally Disintegrating Tablets
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II · Moderate risk
Rizatriptan Benzoate Tablets USP
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II · Moderate risk
Rizatriptan Benzoate Tablets USP
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II · Moderate risk
Duloxetine Delayed-Release Cap USP 30mg
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk
Drug Vial Label: Zilretta¿
Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
Presence of foreign substance: plastic-like substance.
Class II · Moderate risk
Metoprolol Tartrate Tablets USP
Presence of Foreign Substance: metal in tablet
Class II · Moderate risk
Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Class II · Moderate risk
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk
traMADol Hydrochloride Tablets
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Class II · Moderate risk
MethylPREDNISolone Acetate Injectable Suspension
Presence of Particulate Matter: Potential for black particulates in the drug product.
Class II · Moderate risk
Haloperidol decanoate Injection 50mg/mL
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Class II · Moderate risk
Clorazepate Dipotassium Tablets
Discoloration: Dotted and yellow spots on tablets