Class II · Moderate risk Terminated
Glutathione injectable
Reason Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
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Class II · Moderate risk Terminated
Dexpanthenol injectable
Reason Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Calcium Gluconate injectable
Reason Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
CoEnzyme-Q10 injectable
Reason Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class III · Low risk Terminated
Oxycodone and Acetaminophen Tablets
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP 100 mL bags
Reason CGMP Deviations
Class II · Moderate risk Terminated
Thyroid Powder 25kg/drum
Reason CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk Terminated
Montelukast Sodium Tablets
Reason Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Class II · Moderate risk Terminated
Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet
Reason CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Class II · Moderate risk Ongoing
Amlodipine
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Amlodipine
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Amlodipine
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Amlodipine
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Amlodipine
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Valsartan Tablets USP
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Valsartan Tablets USP
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Valsartan Tablets USP
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan Tablets USP 320 mg
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class I · High risk Ongoing
Montelukast Sodium Tablets 10 mg
Reason Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Class III · Low risk Terminated
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO
Reason Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Class II · Moderate risk Terminated
Megestrol Acetate Oral Suspension
Reason Supterpotent Drug