Class II · Moderate risk Ongoing
Dexamethasone-Moxifloxacin- Ketorolac
Reason Lack of Assurance of Sterility
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Dexamethasone-Moxifloxacin
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rizatriptan Benzoate Orally Disintegrating Tablets
Reason CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II · Moderate risk Ongoing
Rizatriptan Benzoate Orally Disintegrating Tablets
Reason CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II · Moderate risk Ongoing
Rizatriptan Benzoate Tablets USP
Reason CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II · Moderate risk Ongoing
Rizatriptan Benzoate Tablets USP
Reason CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Cap USP 30mg
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Drug Vial Label: Zilretta¿
Reason Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
Class II · Moderate risk Ongoing
Losartan Potassium and Hydrochlorothiazide Tablets
Reason Presence of foreign substance: plastic-like substance.
Class II · Moderate risk Ongoing
Metoprolol Tartrate Tablets USP
Reason Presence of Foreign Substance: metal in tablet
Class II · Moderate risk Ongoing
Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free
Reason Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Class II · Moderate risk Ongoing
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE…
Reason Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
traMADol Hydrochloride Tablets
Reason Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Class II · Moderate risk Ongoing
MethylPREDNISolone Acetate Injectable Suspension
Reason Presence of Particulate Matter: Potential for black particulates in the drug product.
Class II · Moderate risk Ongoing
Haloperidol decanoate Injection 50mg/mL
Reason Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Class II · Moderate risk Ongoing
Clorazepate Dipotassium Tablets
Reason Discoloration: Dotted and yellow spots on tablets
Class II · Moderate risk Ongoing
Clorazepate Dipotassium Tablets
Reason Discoloration: Dotted and yellow spots on tablets
Class II · Moderate risk Ongoing
Amphotericin B Liposome for Injection
Reason Out of specification for assay
Class II · Moderate risk Ongoing
Ful-Glo
Reason Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Class II · Moderate risk Ongoing
Ful-Glo
Reason Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Class II · Moderate risk Ongoing
GloStrips
Reason Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.