Class II · Moderate risk Terminated
Netspot
Reason Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
FDA Drug Recalls
17,898 recalls, newest first
Class III · Low risk Terminated
Tri-Lo-Marzia
Reason CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Class II · Moderate risk Terminated
Estriol USP Micronized a) 100 gm NDC 62991-2159-04
Reason Subpotent
Class II · Moderate risk Terminated
Preferred Pharmaceuticals
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Preferred Pharmaceuticals
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Nizatidine Capsules
Reason CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Class II · Moderate risk Terminated
Nizatidine Capsules
Reason CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Class III · Low risk Terminated
Eczema Skin Relief Lotion
Reason Microbial contamination of non-sterile product.
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 I · High risk Terminated
Ketorolac Trom
Reason Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.
Class III · Low risk Terminated
Proparacaine Hydrochloride Ophthalmic Solution
Reason Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
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 I · High risk Terminated
Lamotrigine Tablets
Reason Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
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.