Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
FDA Drug Recalls
1,586 recalls · Class II, newest first
Class II · Moderate risk
Midazolam Benzodiazepine 50 mg/50 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 2500 mcg/250 mL Injectable Solution
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Dr. Berne's MSM DROPS 15% Solution
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk
Red Eye
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk
Dry Eye
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk
15% Msm
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk
Hydrocortisone and Acetic Acid Otic Solution
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Class II · Moderate risk
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Class II · Moderate risk
Volumex (Iodinated I 131 Albumin)
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Class II · Moderate risk
Losartan Potassium USP
CGMP deviation: Product found to contain trace amounts of NMBA
Class II · Moderate risk
Valsartan Tablets 320 mg USP
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class II · Moderate risk
Valsartan Tablets 160 mg USP
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class II · Moderate risk
Valsartan Tablets 80 mg USP
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class II · Moderate risk
Valsartan Tablets 40 mg USP
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class II · Moderate risk
Little Remedies New Baby Essentials Kit. Each kit contains 1 each…
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
Class II · Moderate risk
Valsartan Tablets USP 160 mg
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Class II · Moderate risk
Docetaxel Injection USP
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Class II · Moderate risk
Losartan Potassium Tablets USP 50 mg 50 Tablets
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Class II · Moderate risk
Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).