Class II · Moderate risk Terminated
Nizatidine Capsules
Reason CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Dutasteride Capsules
Reason Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Class II · Moderate risk Terminated
Ranitidine Capsules 150 mg
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Terminated
Ranitidine Capsules 300 mg
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Terminated
Ranitidine
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Sumatriptan Succinate Tablets
Reason Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Class II · Moderate risk Terminated
Sumatriptan Succinate Tablets
Reason Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Class II · Moderate risk Terminated
Ranitidine 150 mg tablets
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Terminated
Ranitidine 150 mg tablets
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Terminated
Blisovi Fe 1.5/30
Reason Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Class II · Moderate risk Terminated
Theraflu Cough Relief
Reason Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, Ask a doctor before use if you have a sodium-restricted diet.
Class II · Moderate risk Terminated
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Trimix Super
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Trimix Forte 4
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Trimix -A
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Trimix
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Testosterone Cyp 200mg/Ml Oil
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
SUFENTANIL 300MCG/ML INJ in 20 mL syringe Assurance Infusion
Reason Lack of sterility assurance.