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