Drug recall: 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Fore

FDA enforcement event 66295 · Class II · initiated 5 Sep 2013 · status Terminated · terminated 28 Oct 2014

DrugVoluntary: Firm initiated1 product recordLake Forest, IL

FDA enforcement event 66295 is a drug recall by Hospira Inc. of Lake Forest, IL, initiated 5 Sep 2013 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 56% of the 370 drug enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 28 Oct 2014. Initiation: voluntary: firm initiated. Hospira Inc. has 151 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Hospira Inc., Lake Forest, IL.

Reason for recall

"Lack of Assurance of Sterility; potential for vial breakage"

Distribution

"Nationwide and Guam and Abu Dhabi"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-66295-001	0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045	187,150 vials	Class II	Terminated	16 Oct 2013

Context

56%of 2013 drug events are Class II370 events that year

1product record in this eventfirm median: 1

151events on this register for the firm

Other enforcement events for Hospira Inc.

Initiated	Product (first record)	Type	Class	Records
21 Apr 2017	Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospir	Drug	Class I	1
1 Nov 2016	Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 6	Drug	Class II	1
15 Aug 2016	DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx	Drug	Class II	1
29 Jun 2016	5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia	Drug	Class III	1
23 Jun 2016	Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32	Drug	Class II	1
6 May 2016	Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01	Drug	Class II	1
25 Mar 2016	The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enter	Device	Class II	2
23 Mar 2016	Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vial	Drug	Class III	1
23 Mar 2016	Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vial	Drug	Class I	1
18 Mar 2016	8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest,	Drug	Class I	1

All 151 events for Hospira Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Lack of Assurance of Sterility; potential for vial breakage"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide and Guam and Abu Dhabi"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 28 Oct 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.