Class II · Moderate risk Terminated
5 mg/mL Ephedrine Sulfate
Reason CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
10 mcg/mL Fentanyl Citrate
Reason CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Class II · Moderate risk Terminated
Prednisolone Sodium Phosphate Oral Solution
Reason Defective Container: Tamper Evident foil seal not completely intact.
Class II · Moderate risk Terminated
Doxycycline Hyclate Tablets
Reason Failed Dissolution Specifications:
Class II · Moderate risk Terminated
Doxycycline Hyclate Tablets
Reason Failed Dissolution Specifications:
Class II · Moderate risk Terminated
AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan HCTZ
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Indomethacin Capsules
Reason Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Class II · Moderate risk Terminated
Potassium Citrate Extended-Release Tablets
Reason Failed Tablet/Capsule Specifications: Tablet breakage
Class II · Moderate risk Terminated
Potassium Citrate Extended-Release Tablets
Reason Failed Tablet/Capsule Specifications: Tablet breakage
Class II · Moderate risk Terminated
Unit Dose Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Unit Dose Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide 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 Terminated
Eyewash Purified water 98.3%
Reason CGMP Deviations
Class II · Moderate risk Terminated
Emergency First Aid Eyewash
Reason CGMP Deviations