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Recall Enforment Report D-381-2014

Recall Details

Multi event Drug Recall Enforcement Report Class I voluntary initiated by Hospira Inc., originally initiated on 07-12-2013 for the product 0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1165-02 The product was recalled due to presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.. 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-381-201407-12-201312-25-2013Class I119,600 vials0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1165-02Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.Terminated
D-380-201407-12-201312-25-2013Class I118,100 vials0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1159-02Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0409-1159Bupivacaine Hydrochloride Bupivacaine HydrochlorideInjection, SolutionEpidural; Infiltration; Intracaudal; PerineuralHospira, Inc.Human Prescription Drug
0409-1159Bupivacaine Hydrochloride Bupivacaine HydrochlorideInjection, SolutionEpidural; Infiltration; Intracaudal; PerineuralHospira, Inc.Human Prescription Drug
0409-1160Bupivacaine Hydrochloride Bupivacaine HydrochlorideInjection, SolutionInfiltration; PerineuralHospira, Inc.Human Prescription Drug
0409-1162Bupivacaine Hydrochloride Hospira, Inc.
0409-1162Bupivacaine Hydrochloride Bupivacaine HydrochlorideInjection, SolutionEpidural; Intracaudal; PerineuralHospira, Inc.Human Prescription Drug
0409-1163Bupivacaine Hydrochloride Bupivacaine HydrochlorideInjection, SolutionPerineuralHospira, Inc.Human Prescription Drug
0409-1165Bupivacaine Hydrochloride Bupivacaine HydrochlorideInjection, SolutionEpidural; RetrobulbarHospira, Inc.Human Prescription Drug
0409-9042Bupivacaine Hydrochloride And Epinephrine Hospira, Inc.
0409-9042Bupivacaine Hydrochloride And Epinephrine Bupivacaine Hydrochloride And EpinephrineInjection, SolutionEpidural; Infiltration; Intracaudal; PerineuralHospira, Inc.Human Prescription Drug
0409-9043Bupivacaine Hydrochloride And Epinephrine Bupivacaine Hydrochloride And EpinephrineInjection, SolutionInfiltration; PerineuralHospira, Inc.Human Prescription Drug
0409-9045Bupivacaine Hydrochloride And Epinephrine Bupivacaine Hydrochloride And EpinephrineInjection, SolutionEpidural; Intracaudal; PerineuralHospira, Inc.Human Prescription Drug
0409-9046Bupivacaine Hydrochloride And Epinephrine Bupivacaine Hydrochloride And EpinephrineInjection, SolutionPerineuralHospira, Inc.Human Prescription Drug