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  3. Recall Enforcement Event ID: 69573

Recall Enforment Report D-0389-2015

Recall Details

Multi event Drug Recall Enforcement Report Class I voluntary initiated by Hospira Inc., originally initiated on 10-06-2014 for the product Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30. The product was recalled due to temperature abuse: products experienced uncontrolled temperature excursions during transit.. 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-0389-201510-06-201402-25-2015Class I2,500 vialsPropofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.Terminated
D-0390-201510-06-201402-25-2015Class II90,600 vialsVancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-6533-01.Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.Terminated
D-0387-201510-06-201402-25-2015Class II200 vialsVancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4332-01.Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.Terminated
D-0388-201510-06-201402-25-2015Class II100 vialsKetorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-3796-01.Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0409-3515Vancomycin Hydrochloride Vancomycin HydrochlorideInjection, Powder, Lyophilized, For SolutionIntravenousHospira, Inc.Human Prescription Drug
0409-3793Ketorolac Tromethamine Hospira, Inc.
0409-3793Ketorolac Tromethamine Ketorolac TromethamineInjection, SolutionIntramuscular; IntravenousHospira, Inc.Human Prescription Drug
0409-3795Ketorolac Tromethamine Hospira, Inc.
0409-3795Ketorolac Tromethamine Ketorolac TromethamineInjection, SolutionIntramuscular; IntravenousHospira, Inc.Human Prescription Drug
0409-3796Ketorolac Tromethamine Hospira, Inc.
0409-3796Ketorolac Tromethamine Ketorolac TromethamineInjection, SolutionIntramuscularHospira, Inc.Human Prescription Drug
0409-4332Vancomycin Hydrochloride Hospira, Inc.
0409-4332Vancomycin Hydrochloride Vancomycin HydrochlorideInjection, Powder, Lyophilized, For SolutionIntravenousHospira, Inc.Human Prescription Drug
0409-4699Propofol PropofolInjection, EmulsionIntravenousHospira, Inc.Human Prescription Drug
0409-6010Propofol PropofolInjection, EmulsionIntravenousHospira, Inc.Human Prescription Drug
0409-6531Vancomycin Hydrochloride Vancomycin HydrochlorideInjection, Powder, Lyophilized, For SolutionIntravenousHospira, Inc.Human Prescription Drug
0409-6531Vancomycin Hydrochloride Vancomycin HydrochlorideInjection, Powder, Lyophilized, For SolutionIntravenousHospira, Inc.Human Prescription Drug
0409-6533Vancomycin Hydrochloride Vancomycin HydrochlorideInjection, Powder, Lyophilized, For SolutionIntravenousHospira, Inc.Human Prescription Drug
0409-6533Vancomycin Hydrochloride Vancomycin HydrochlorideInjection, Powder, Lyophilized, For SolutionIntravenousHospira, Inc.Human Prescription Drug