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.
FDA Drug Recalls
11,815 recalls · Class II, newest first
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 Terminated
Valsartan Tablets USP 320 mg
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Megestrol Acetate Oral Suspension
Reason Supterpotent Drug
Class II · Moderate risk Terminated
Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Lisinopril Tablets USP
Reason Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Class II · Moderate risk Terminated
Valsartan 320 mg Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan 160 mg Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan 80 mg Tablet
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Cyclosporine 1% Human Eye Drops
Reason Lack of Process Controls
Class II · Moderate risk Terminated
ADAA Cataract Drops
Reason Lack of Process Controls
Class II · Moderate risk Terminated
Alprostadil 500 mcg/mL Injectable
Reason Incorrect Product Formulation
Class II · Moderate risk Terminated
Doxycycline Hyclate USP Tablets
Reason Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.
Class II · Moderate risk Terminated
PIO&METFORMIN 15/1000 mg Tab 1
Reason 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 Terminated
Metformin Hydrochloride Extended Release Tablets 1000 mg
Reason 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 Terminated
Metformin Hydrochloride Extended Release Tablets 1000 mg
Reason 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 Terminated
Metformin Hydrochloride Extended Release Tablets
Reason 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 Terminated
Fortamet
Reason 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 Terminated
Paliperidone Extended Release Tablets 9 mg
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.