Class II · Moderate risk Ongoing
Amlodipine
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
FDA Drug Recalls
14,450 recalls · Class II, newest first
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 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