Class II · Moderate risk
Heparin 5
Lack of Assurance of Sterility
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Class II · Moderate risk
Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Esmolol HCl Injectable Solution 100 mg/10 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
2% Lidocaine HCl Injectable Solution
Lack of Assurance of Sterility
Class II · Moderate risk
2% Lidocaine HCl Injectable Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Glycopyrrolate 0.6 mg/3 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Neostigmine Methylsulfate Injection Solution 5 mg/5mL
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Glycopyrrolate Injectable Solution 1 mg/5 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
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 III · Low risk
Testosterone Topical Solution
Defective Container: Repetitive complaints received indicating pump not working.
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 III · Low risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Subpotent Drug.