Class II · Moderate risk
Nizatidine Capsules
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
FDA Drug Recalls
832 recalls, newest first
Class II · Moderate risk
Nizatidine Capsules
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Class III · Low risk
Eczema Skin Relief Lotion
Microbial contamination of non-sterile product.
Class II · Moderate risk
Dutasteride Capsules
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Class II · Moderate risk
Ranitidine Capsules 150 mg
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine Capsules 300 mg
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine
CGMP Deviations: Presence of NDMA impurity detected in product.