Class II · Moderate risk Terminated
Ascend Laboratories
Reason Failed Impurity/Degradation Specifications
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Dexamethasone - Moxifloxacin PF Injection
Reason Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
Class II · Moderate risk Terminated
Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only
Reason Subpotent drug.
Class II · Moderate risk Terminated
Azacitidine for Injection 100 mg/vial For Subcutaneous and…
Reason cGMP deviations: Vials may not be sealed correctly affecting sterility.
Class II · Moderate risk Terminated
Sensorcaine-MPF
Reason Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Class II · Moderate risk Terminated
Hydroxyzine Hydrochloride Oral Solution
Reason Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Class II · Moderate risk Terminated
Auryxia
Reason CGMP Deviations
Class II · Moderate risk Terminated
Vumerity
Reason Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Class II · Moderate risk Terminated
Docetaxel Injection USP 160 mg/8mL
Reason CGMP Deviations
Class II · Moderate risk Terminated
Imatinib Mesylate Tablets 400 mg
Reason CGMP Deviations
Class II · Moderate risk Terminated
Imatinib Mesylate Tablets 100 mg
Reason CGMP Deviations
Class II · Moderate risk Terminated
Azacitidine for Injection 100 mg/vial
Reason CGMP Deviations
Class II · Moderate risk Terminated
Azacitidine for Injection 100 mg/vial
Reason CGMP Deviations
Class II · Moderate risk Terminated
Busulfan Injection 60 mg/10 mL
Reason CGMP Deviations
Class II · Moderate risk Terminated
Sodium Chloride Injection
Reason Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Class II · Moderate risk Terminated
Sildenafil Tablets USP 100 mg
Reason Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Lavar 70 Gel Hand Sanitizer 70% Alcohol Content
Reason Subpotent drug
Class II · Moderate risk Terminated
UVT World Gel Hand Sanitizer 70% Alcohol Content
Reason Subpotent drug
Class II · Moderate risk Terminated
Health & Hand Gel Hand Sanitizer 70% Alcohol Content
Reason Subpotent drug
Class II · Moderate risk Terminated
CitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent
Reason Subpotent drug
Class II · Moderate risk Terminated
+Protec Hands Antibacterial Gel Topical Solution Instant…
Reason Subpotent drug
Class II · Moderate risk Terminated
Tizanidine Tablets
Reason Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Class II · Moderate risk Terminated
Cephalexin for Oral Suspension
Reason Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.