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
11,818 recalls · Class II, 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 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
Valsartan Tablets USP 320 mg
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Megestrol Acetate Oral Suspension
Supterpotent Drug
Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Lisinopril Tablets USP
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Class II · Moderate risk
Valsartan 320 mg Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan 160 mg Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan 80 mg Tablet
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Cyclosporine 1% Human Eye Drops
Lack of Process Controls
Class II · Moderate risk
ADAA Cataract Drops
Lack of Process Controls
Class II · Moderate risk
Alprostadil 500 mcg/mL Injectable
Incorrect Product Formulation
Class II · Moderate risk
Doxycycline Hyclate USP Tablets
Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.
Class II · Moderate risk
PIO&METFORMIN 15/1000 mg Tab 1
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Metformin Hydrochloride Extended Release Tablets 1000 mg
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Metformin Hydrochloride Extended Release Tablets 1000 mg
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.