Class II · Moderate risk Terminated
Emergency First Aid Eyewash
Reason CGMP Deviations
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Valsartan/HCTZ 320mg/12.5 mg tablet
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan/HCTZ 160 mg/12.5 mg tablet
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Omega-3-Acid Ethyl Esters Capsules USP
Reason API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Solco Healthcare US Valsartan and Hydrochlorothiazide
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Solco Healthcare US Valsartan and Hydrochlorothiazide
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Solco Healthcare US Valsartan and Hydrochlorothiazide
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Solco Healthcare US Valsartan and Hydrochlorothiazide
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Solco Healthcare US Valsartan and Hydrochlorothiazide
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Solco Healthcare US Valsartan
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Solco Healthcare US Valsartan
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Solco Healthcare US Valsartan
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Solco Healthcare US Valsartan
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Class III · Low risk Terminated
Fluconazole Injection
Reason Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Class III · Low risk Terminated
Fluconazole Injection
Reason Failed Stability Specifications: lot out of specification for elevated water vapor.