Class II · Moderate risk Terminated
Phenylephrine HCl
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Midazolam Benzodiazepine 50 mg/50 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 2500 mcg/250 mL Injectable Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Dr. Berne's MSM DROPS 15% Solution
Reason Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk Terminated
Red Eye
Reason Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk Terminated
Dry Eye
Reason Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk Terminated
15% Msm
Reason Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk Terminated
Hydrocortisone and Acetic Acid Otic Solution
Reason Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Class II · Moderate risk Terminated
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By…
Reason CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Class II · Moderate risk Terminated
Volumex
Reason Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Class II · Moderate risk Terminated
Losartan Potassium USP
Reason CGMP deviation: Product found to contain trace amounts of NMBA
Class II · Moderate risk Ongoing
Valsartan Tablets 320 mg USP
Reason CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class II · Moderate risk Ongoing
Valsartan Tablets 160 mg USP
Reason CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class II · Moderate risk Ongoing
Valsartan Tablets 80 mg USP
Reason CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class II · Moderate risk Ongoing
Valsartan Tablets 40 mg USP
Reason CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class II · Moderate risk Terminated
Little Remedies New Baby Essentials Kit. Each kit contains 1 each…
Reason Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
Class II · Moderate risk Terminated
Valsartan Tablets USP 160 mg
Reason CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Class II · Moderate risk Terminated
Docetaxel Injection USP
Reason Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Class II · Moderate risk Terminated
Losartan Potassium and Hydrochlorothiazide Tablets
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Class II · Moderate risk Terminated
Losartan Potassium and Hydrochlorothiazide Tablets
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Class II · Moderate risk Terminated
Losartan Potassium Tablets USP 50 mg 50 Tablets
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Class II · Moderate risk Terminated
Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP
Reason CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).