1. Home
  2. Drug Recall Enforcement Reports
  3. Recall Enforcement Event ID: 63451

Recall Enforment Report D-0295-2015

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Fresenius Kabi USA, LLC, originally initiated on 09-27-2012 for the product MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25. The product was recalled due to lack of assurance of sterility: glass vials may have finish fractures and glass particles.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0295-201509-27-201212-17-2014Class II101,200 VialsMIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.Terminated
D-0296-201509-27-201212-17-2014Class II184,550 VialsONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.Terminated
D-0297-201509-27-201212-17-2014Class II240,550 VialsCYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-044-01.Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
63323-044Cyanocobalamin CyanocobalaminInjection, SolutionIntramuscular; SubcutaneousFresenius Kabi Usa, LlcHuman Prescription Drug
63323-044Cyanocobalamin CyanocobalaminInjection, SolutionIntramuscular; SubcutaneousFresenius Kabi Usa, LlcHuman Prescription Drug
63323-373Ondansetron Ondansetron HydrochlorideInjectionIntramuscular; IntravenousFresenius Kabi Usa, LlcHuman Prescription Drug
63323-374Ondansetron Ondansetron HydrochlorideInjectionIntramuscular; IntravenousFresenius Kabi Usa, LlcHuman Prescription Drug
63323-411Midazolam Midazolam HydrochlorideInjection, SolutionIntramuscular; IntravenousFresenius Kabi Usa, LlcHuman Prescription Drug
63323-412Midazolam Midazolam HydrochlorideInjection, SolutionIntramuscular; IntravenousFresenius Kabi Usa, LlcHuman Prescription Drug
63323-412Midazolam Midazolam HydrochlorideInjection, SolutionIntramuscular; IntravenousFresenius Kabi Usa, LlcHuman Prescription Drug