Class II · Moderate risk
Glutathione injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
Class II · Moderate risk
Dexpanthenol injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
Calcium Gluconate injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
CoEnzyme-Q10 injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class III · Low risk
Oxycodone and Acetaminophen Tablets
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
0.9% Sodium Chloride Injection USP 100 mL bags
CGMP Deviations
Class II · Moderate risk
Thyroid Powder 25kg/drum
CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk
Montelukast Sodium Tablets
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Class II · Moderate risk
Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Class II · Moderate risk
Amlodipine
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets USP
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets USP
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets USP
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets USP 320 mg
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class I · High risk
Montelukast Sodium Tablets 10 mg
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
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Class II · Moderate risk
Megestrol Acetate Oral Suspension
Supterpotent Drug