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Recall Enforment Report D-0627-2021

Recall Details

Multi event Drug Recall Enforcement Report Class I voluntary initiated by PFIZER, INC, originally initiated on 05-03-2021 for the product 1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vials per tray (NDC 0409-4279-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. The product was recalled due to labeling: label mix-up: some vials labeled to contain 0.5% bupivacaine hydrochloride injection, usp may contain 1% lidocaine hcl injection, usp and some vials labeled to contain 1% lidocaine hcl injection, usp may contain 0.5% bupivacaine hydrochloride injection, usp. 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-0627-202105-03-202106-09-2021Class I139,050 vials1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vials per tray (NDC 0409-4279-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USPTerminated
D-0626-202105-03-202106-09-2021Class I163,957 vials0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19), packaged in 25 vials per tray (NDC 0409-1162-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USPTerminated

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
0409-4275Lidocaine Hydrochloride Lidocaine HydrochlorideInjection, SolutionInfiltration; PerineuralHospira, Inc.Human Prescription Drug
0409-4276Lidocaine Hydrochloride Lidocaine HydrochlorideInjection, SolutionInfiltration; PerineuralHospira, Inc.Human Prescription Drug
0409-4277Lidocaine Hydrochloride Lidocaine HydrochlorideInjection, SolutionInfiltration; PerineuralHospira, Inc.Human Prescription Drug
0409-4278Lidocaine Hydrochloride Lidocaine HydrochlorideInjection, SolutionInfiltration; IntravenousHospira, Inc.Human Prescription Drug
0409-4279Lidocaine Hydrochloride Lidocaine HydrochlorideInjection, SolutionEpidural; Infiltration; Intracaudal; PerineuralHospira, Inc.Human Prescription Drug
0409-4282Lidocaine Hydrochloride Lidocaine HydrochlorideInjection, SolutionEpidural; Infiltration; Intracaudal; PerineuralHospira, Inc.Human Prescription Drug
0409-4713Lidocaine Hydrochloride Lidocaine HydrochlorideInjection, SolutionEpidural; Infiltration; Intracaudal; PerineuralHospira, Inc.Human Prescription Drug
0409-4776Lidocaine Hydrochloride Lidocaine HydrochlorideInjection, SolutionEpidural; Infiltration; Intracaudal; PerineuralHospira, 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