Class II · Moderate risk
AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan HCTZ
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Indomethacin Capsules
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Class II · Moderate risk
Potassium Citrate Extended-Release Tablets
Failed Tablet/Capsule Specifications: Tablet breakage
Class II · Moderate risk
Potassium Citrate Extended-Release Tablets
Failed Tablet/Capsule Specifications: Tablet breakage
Class II · Moderate risk
Unit Dose Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Unit Dose Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan and Hydrochlorothiazide Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan and Hydrochlorothiazide 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
Eyewash Purified water 98.3%
CGMP Deviations
Class II · Moderate risk
Emergency First Aid Eyewash
CGMP Deviations
Class II · Moderate risk
Valsartan/HCTZ 320mg/12.5 mg tablet
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan/HCTZ 160 mg/12.5 mg tablet
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Omega-3-Acid Ethyl Esters Capsules USP
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
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.