Manufacturers/Hospira Inc.

Hospira Inc.

119 drugs in NADAC|117 Generic,2 Brand

View Recalls (50)

Hospira Inc. lists 119 NDCs in the CMS NADAC file (117 generic, 2 brand), at an average NADAC of $4.29 per unit, with a week-over-week move of +1.3% across products that moved. The firm's full portfolio, pricing trend, and FDA recalls are listed below.

Total Drugs

119

117G / 2B

Avg Price / Unit

$4.2938

$0.02 – $43.35

Avg 7d Change

+1.34%

Across 46 drugs with changes

7d Activity

27↑19↓73 flat

of 119 total drugs

Portfolio Price Trend

Monthly average NADAC price across all drugs

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Frequently Asked Questions

How many drugs does Hospira Inc. make?

Hospira Inc. lists 119 NDCs in the CMS NADAC file — 117 generic and 2 brand products.

What is the average price of Hospira Inc. drugs?

The average NADAC across Hospira Inc.'s portfolio is $4.2938 per unit, ranging from $0.0210 to $43.3460.

What types of drugs does Hospira Inc. make?

Hospira Inc. makes drugs across 36 FDA pharmacologic classes. The most common by NDC count are Cephalosporin Antibacterial (13), Benzodiazepine (10), Amide Local Anesthetic (10), Antiarrhythmic (9), Opioid Agonist (7).

Has Hospira Inc. had any drug recalls?

50 FDA recalls are matched to Hospira Inc. in the openFDA feed, most recently on Feb 20, 2018.

How has Hospira Inc.'s pricing changed recently?

Over the past 7 days, 27 Hospira Inc. products rose and 19 fell, with a portfolio-wide average change of +1.3%.

Drug Portfolio

119 drugs total, 119 shown

Drug ↕Price 7d Change ↕
BORTEZOMIB 3.5 MG VIAL
Bortezomib
$43.3460
per EA
—
VANCOMYCIN HCL 5 GM VIAL
VANCOMYCIN HYDROCHLORIDE
$39.3160
per EA
—
VANCOMYCIN HCL 5 GM VIAL
VANCOMYCIN HYDROCHLORIDE
$39.3160
per EA
—
VITAMIN K-1 10 MG/ML AMPUL
PHYTONADIONE
$30.7816
per ML
—
ERTAPENEM 1 GRAM VIAL
Ertapenem
$26.6295
per EA
-4.06%
BLEOMYCIN SULFATE 15 UNIT VIAL
BLEOMYCIN
$26.4480
per EA
—
BLEOMYCIN SULFATE 15 UNIT VIAL
BLEOMYCIN
$26.4480
per EA
—
CEFTRIAXONE 10 GM VIAL
Ceftriaxone Sodium
$25.2133
per EA
—
DAPTOMYCIN 500 MG VIAL
DAPTOMYCIN
$20.7686
per EA
—
GEMCITABINE HCL 1 GRAM VIAL
GEMCITABINE
$19.9960
per EA
—
NALOXONE 0.4 MG/ML VIAL
NALOXONE HYDROCHLORIDE
$15.7839
per ML
—
NALOXONE 0.4 MG/ML CARPUJECT
NALOXONE HYDROCHLORIDE
$15.2708
per ML
—
DAPTOMYCIN 350 MG VIAL
DAPTOMYCIN
$13.4180
per EA
—
TESTOSTERONE CYP 200 MG/ML
testosterone cypionate
$11.3924
per ML
-1.33%
TAZICEF 2 GRAM VIAL
CEFTAZIDIME
$9.5080
per EA
—
VANCOMYCIN 1 GM ADD-VAN VIAL
VANCOMYCIN HYDROCHLORIDE
$6.4880
per EA
—
CEFEPIME HCL 2 GRAM VIAL
Cefepime
$5.3480
per EA
—
DIAZEPAM 5 MG/ML SYRINGE
DIAZEPAM
$5.2875
per ML
—
MEROPENEM IV 1 GM VIAL
Meropenem
$4.6875
per EA
+0.40%
MEROPENEM IV 1 GM VIAL
Meropenem
$4.6875
per EA
+0.40%
TESTOSTERONE CYP 1,000 MG/10 ML
testosterone cypionate
$4.5281
per ML
-9.36%
DEMEROL 50 MG/ML SYRINGE
MEPERIDINE HYDROCHLORIDE
$4.4738
per ML
—
NALBUPHINE 10 MG/ML AMPUL
NALBUPHINE HYDROCHLORIDE
$4.3216
per ML
—
NALBUPHINE 10 MG/ML AMPUL
NALBUPHINE HYDROCHLORIDE
$4.3216
per ML
—
NALOXONE 0.4 MG/ML VIAL
NALOXONE HYDROCHLORIDE
$3.8243
per ML
-4.74%
TAZICEF 1 GRAM VIAL
CEFTAZIDIME
$3.7508
per EA
—
CEFEPIME HCL 1 GM VIAL
Cefepime
$3.7308
per EA
—
TESTOSTERONE CYP 2,000 MG/10 ML
testosterone cypionate
$3.5819
per ML
-1.89%
HYDROMORPHONE 2 MG/ML CARPUJCT
HYDROMORPHONE HYDROCHLORIDE
$3.2446
per ML
—
METHOTREXATE 50 MG/2 ML VIAL
Methotrexate
$3.1832
per ML
+1.75%
METHOTREXATE 50 MG/2 ML VIAL
Methotrexate
$3.1832
per ML
+1.75%
METHOTREXATE 50 MG/2 ML VIAL
Methotrexate
$3.1832
per ML
+1.75%
VANCOMYCIN 1 GM VIAL
VANCOMYCIN HYDROCHLORIDE
$2.9591
per EA
—
VANCOMYCIN 1 GM VIAL
VANCOMYCIN HYDROCHLORIDE
$2.9591
per EA
—
MEROPENEM IV 500 MG VIAL
Meropenem
$2.8678
per EA
—
MEROPENEM IV 500 MG VIAL
Meropenem
$2.8678
per EA
—
CEFTRIAXONE 2 GM VIAL
Ceftriaxone Sodium
$2.8330
per EA
+4.93%
CEFTRIAXONE 2 GM VIAL
Ceftriaxone Sodium
$2.8330
per EA
+4.93%
HYDROMORPHONE 50 MG/5 ML VIAL
Hydromorphone Hydrochloride
$2.5663
per ML
—
HYDROMORPHONE 500 MG/50 ML VIAL
Hydromorphone Hydrochloride
$2.5663
per ML
—
VANCOMYCIN 500 MG VIAL
VANCOMYCIN HYDROCHLORIDE
$2.3054
per EA
—
PACLITAXEL 30 MG/5 ML VIAL
PACLITAXEL
$2.1290
per ML
—
HEPARIN SODIUM 10,000 UNIT/ML VIAL
HEPARIN SODIUM
$2.0940
per ML
-0.09%
PACLITAXEL 100 MG/16.7 ML VIAL
PACLITAXEL
$1.8891
per ML
—
MORPHINE 2 MG/ML CARPUJECT
MORPHINE SULFATE
$1.8340
per ML
—
FENTANYL 100 MCG/2 ML VIAL
FENTANYL CITRATE
$1.7864
per ML
+3.44%
KETAMINE 500 MG/5 ML VIAL
KETAMINE HYDROCHLORIDE
$1.7804
per ML
+15.34%
KETAMINE 500 MG/5 ML VIAL
Ketamine Hydrochloride
$1.7804
per ML
+15.34%
PACLITAXEL 300 MG/50 ML VIAL
PACLITAXEL
$1.7700
per ML
—
MORPHINE 10 MG/ML CARPUJECT
MORPHINE SULFATE
$1.5952
per ML
—
CEFTRIAXONE 500 MG VIAL
Ceftriaxone Sodium
$1.3139
per EA
+1.26%
CEFTRIAXONE 500 MG VIAL
Ceftriaxone Sodium
$1.3139
per EA
+1.26%
GENTAMICIN 80 MG/2 ML VIAL
GENTAMICIN SULFATE
$1.3026
per ML
-4.04%
MIDAZOLAM HCL 5 MG/ML VIAL
MIDAZOLAM HYDROCHLORIDE
$1.2259
per ML
+0.36%
MIDAZOLAM HCL 5 MG/ML VIAL
MIDAZOLAM HYDROCHLORIDE
$1.2259
per ML
+0.36%
EPINEPHRINE 1 MG/10 ML ABBOJCT
epinephrine
$1.1940
per ML
—
HEPARIN SODIUM 5,000 UNIT/ML VIAL
HEPARIN SODIUM
$1.1796
per ML
+0.66%
CEFTRIAXONE 1 GM VIAL
Ceftriaxone Sodium
$1.1732
per EA
-1.86%
CEFTRIAXONE 1 GM VIAL
Ceftriaxone Sodium
$1.1732
per EA
-1.86%
KETOROLAC 30 MG/ML VIAL
KETOROLAC TROMETHAMINE
$1.0175
per ML
-2.61%
CARBOPLATIN 150 MG/15 ML VIAL
Carboplatin
$0.9933
per ML
—
KETOROLAC 15 MG/ML VIAL
KETOROLAC TROMETHAMINE
$0.9459
per ML
—
KETOROLAC 15 MG/ML VIAL
KETOROLAC TROMETHAMINE
$0.9459
per ML
—
CEFTRIAXONE 250 MG VIAL
Ceftriaxone Sodium
$0.8622
per EA
—
CEFTRIAXONE 250 MG VIAL
Ceftriaxone Sodium
$0.8622
per EA
—
TOBRAMYCIN 80 MG/2 ML VIAL
TOBRAMYCIN
$0.8315
per ML
+12.45%
ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$0.7371
per ML
-0.57%
METHOTREXATE 1 GRAM/40 ML VIAL
Methotrexate
$0.6450
per ML
—
METHOTREXATE 1 GRAM/40 ML VIAL
Methotrexate
$0.6450
per ML
—
ACETYLCYSTEINE 10% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$0.6356
per ML
+0.08%
MIDAZOLAM HCL 10 MG/2 ML VIAL
MIDAZOLAM HYDROCHLORIDE
$0.5652
per ML
-0.34%
MIDAZOLAM HCL 10 MG/2 ML VIAL
MIDAZOLAM HYDROCHLORIDE
$0.5652
per ML
-0.34%
KETAMINE 500 MG/10 ML VIAL
Ketamine Hydrochloride
$0.5563
per ML
-0.30%
KETOROLAC 60 MG/2 ML VIAL
KETOROLAC TROMETHAMINE
$0.5524
per ML
+10.91%
METOCLOPRAMIDE 10 MG/2 ML VIAL
metoclopramide
$0.5290
per ML
—
METOCLOPRAMIDE 10 MG/2 ML VIAL
metoclopramide
$0.5290
per ML
—
METOCLOPRAMIDE 10 MG/2 ML VIAL
metoclopramide
$0.5290
per ML
—
METOCLOPRAMIDE 10 MG/2 ML VIAL
metoclopramide
$0.5290
per ML
—
KETOROLAC 60 MG/2 ML VIAL
KETOROLAC TROMETHAMINE
$0.4980
per ML
—
FUROSEMIDE 20 MG/2 ML VIAL
FUROSEMIDE
$0.4901
per ML
+6.18%
FUROSEMIDE 20 MG/2 ML VIAL
FUROSEMIDE
$0.4901
per ML
+6.18%
LIDOCAINE HCL 2% SYRINGE
LIDOCAINE HYDROCHLORIDE
$0.4706
per ML
—
MIDAZOLAM HCL 2 MG/2 ML VIAL
MIDAZOLAM HYDROCHLORIDE
$0.4200
per ML
—
MIDAZOLAM HCL 2 MG/2 ML VIAL
MIDAZOLAM HYDROCHLORIDE
$0.4200
per ML
—
ROCURONIUM 50 MG/5 ML VIAL
Rocuronium Bromide
$0.3942
per ML
—
ROCURONIUM 50 MG/5 ML VIAL
Rocuronium Bromide
$0.3942
per ML
—
ROCURONIUM 50 MG/5 ML VIAL
rocuronium bromide
$0.3942
per ML
—
ROCURONIUM 50 MG/5 ML VIAL
rocuronium bromide
$0.3942
per ML
—
MIDAZOLAM HCL 50 MG/10 ML VIAL
MIDAZOLAM HYDROCHLORIDE
$0.3817
per ML
—
LIDOCAINE HCL 2% 100 MG/5 ML
Lidocaine Hydrochloride
$0.3487
per ML
—
SODIUM BICARB 8.4% ABBOJECT
Sodium Bicarbonate
$0.3288
per ML
—
WATER FOR INJECTION VIAL
WATER
$0.3150
per ML
+2.41%
WATER FOR INJECTION VIAL
WATER
$0.3150
per ML
+2.41%
FUROSEMIDE 40 MG/4 ML VIAL
FUROSEMIDE
$0.2525
per ML
-4.99%
FUROSEMIDE 40 MG/4 ML VIAL
FUROSEMIDE
$0.2525
per ML
-4.99%
LIDOCAINE HCL 1% AMPUL
LIDOCAINE HYDROCHLORIDE
$0.2502
per ML
—
MIDAZOLAM HCL 1 MG/ML VIAL
MIDAZOLAM HYDROCHLORIDE
$0.2185
per ML
—
MIDAZOLAM HCL 1 MG/ML VIAL
MIDAZOLAM HYDROCHLORIDE
$0.2185
per ML
—
BACTERIOSTATIC WATER VIAL
Bacteriostatic Water
$0.1924
per ML
+12.52%
ONDANSETRON HCL 4 MG/2 ML VIAL
ONDANSETRON
$0.1759
per ML
-0.69%
ONDANSETRON HCL 4 MG/2 ML VIAL
ONDANSETRON
$0.1759
per ML
-0.69%
ONDANSETRON 40 MG/20 ML VIAL
ONDANSETRON
$0.1730
per ML
+1.77%
PROPOFOL 200 MG/20 ML VIAL
PROPOFOL
$0.1709
per ML
—
SODIUM BICARBONATE 8.4% VIAL
SODIUM BICARBONATE
$0.1540
per ML
—
SODIUM BICARBONATE 8.4% VIAL
SODIUM BICARBONATE
$0.1540
per ML
—
LIDOCAINE 2%-EPI 1:100,000
LIDOCAINE HYDROCHLORIDE and EPINEPHRINE
$0.1340
per ML
—
DEXTROSE 50%-WATER SYRINGE
DEXTROSE MONOHYDRATE
$0.1326
per ML
—
MARCAINE 0.5% VIAL
BUPIVACAINE HYDROCHLORIDE
$0.0977
per ML
—
SODIUM CHLORIDE 0.9% VIAL
Sodium Chloride
$0.0887
per ML
+0.48%
SODIUM CHLORIDE 0.9% VIAL
Sodium Chloride
$0.0887
per ML
+0.48%
LIDOCAINE 1%-EPI 1:100,000
LIDOCAINE HYDROCHLORIDE and EPINEPHRINE
$0.0883
per ML
—
LIDOCAINE HCL 2% VIAL
LIDOCAINE HYDROCHLORIDE
$0.0762
per ML
-4.25%
LIDOCAINE HCL 1% VIAL
LIDOCAINE HYDROCHLORIDE
$0.0700
per ML
+0.87%
WATER FOR INJECTION VIAL
WATER
$0.0661
per ML
—
SODIUM CHLORIDE 0.9% VIAL
Sodium Chloride
$0.0584
per ML
—
LIDOCAINE HCL 2% VIAL
LIDOCAINE HYDROCHLORIDE
$0.0569
per ML
—
LIDOCAINE HCL 1% VIAL
LIDOCAINE HYDROCHLORIDE
$0.0542
per ML
—
BACTERIOSTATIC SALINE VIAL
SODIUM CHLORIDE
$0.0273
per ML
—
SODIUM CHLORIDE 0.9% SOLN
Sodium Chloride
$0.0210
per ML
—

FDA Recalls (50)

Recalls matched by company name. Verify current status with FDA.

D-0576-2018 →
Terminated
Class II

Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-20; and b) NOVAPLUS, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-25.

Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.

Initiated: 2/20/2018
D-0980-2017 →
Terminated
Class III

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01

Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point

Initiated: 7/6/2017
D-0898-2017 →
Terminated
Class II

Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04

GMP Deviation; A foreign stopper was observed during packaging of a lot of product.

Initiated: 5/18/2017
D-0862-2017 →
Ongoing
Class I

Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1775-10

Presence of Particulate Matter: human hair found within an internal sample syringe.

Initiated: 4/21/2017
D-0480-2017 →
Terminated
Class II

METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24

Lack of Sterility Assurance: customer report of leaking bag

Initiated: 2/10/2017
D-0638-2017 →
Terminated
Class I

Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01

Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.

Initiated: 1/24/2017
D-0153-2017 →
Terminated
Class II

Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32

Lack of Assurance of Sterility: Complaints of broken tips on the ampules.

Initiated: 11/1/2016
D-0096-2017 →
Terminated
Class II

Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50.

Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.

Initiated: 9/16/2016
D-0097-2017 →
Terminated
Class II

Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.

Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.

Initiated: 9/16/2016
D-1500-2016 →
Terminated
Class II

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 Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20

Discoloration: Firm received complaints of product discoloration and particulates.

Initiated: 8/15/2016
D-0218-2017 →
Ongoing
Class I

Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02

Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.

Initiated: 8/4/2016
D-0169-2017 →
Terminated
Class III

5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01

Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.

Initiated: 6/29/2016
D-1359-2016 →
Terminated
Class II

Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32

Crystallization: Product contains particulate identified to be crystallized active ingredient.

Initiated: 6/23/2016
D-1033-2016 →
Terminated
Class II

Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01

Presence of Particulate Matter: Cardboard

Initiated: 5/6/2016
D-0854-2016 →
Ongoing
Class III

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 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.

Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.

Initiated: 3/23/2016
D-1137-2016 →
Ongoing
Class I

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 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.

Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.

Initiated: 3/23/2016
D-0865-2016 →
Ongoing
Class I

8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02

Presence of Particulate Matter: particulate matter identified as an insect in one vial.

Initiated: 3/18/2016
D-0836-2016 →
Ongoing
Class III

Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA, NDC 0409-6629-02

Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.

Initiated: 3/15/2016
D-0828-2016 →
Terminated
Class II

Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7936-19, Barcode (01) 0 030409 793619 9

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Initiated: 3/8/2016
D-0830-2016 →
Terminated
Class II

Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-03 Barcode (01) 0 030409 417803 5

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Initiated: 3/8/2016
D-0831-2016 →
Terminated
Class II

Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Initiated: 3/8/2016
D-0827-2016 →
Terminated
Class II

Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7918-19, Barcode (01) 0 030409 791819 5

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Initiated: 3/8/2016
D-0832-2016 →
Terminated
Class II

Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7077-14

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Initiated: 3/8/2016
D-0829-2016 →
Terminated
Class II

Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7935-19, Barcode (01) 0 030409 793519 2

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Initiated: 3/8/2016
D-0727-2016 →
Ongoing
Class III

Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0.

Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".

Initiated: 2/2/2016
D-0668-2016 →
Terminated
Class I

Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6729-24.

Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.

Initiated: 1/5/2016
D-0054-2016 →
Ongoing
Class III

Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-8060-29

Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.

Initiated: 9/29/2015
D-0418-2015 →
Terminated
Class II

Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05

Defective Container: There were customer complaints of cracked and leaking glass vials.

Initiated: 8/20/2015
D-1240-2015 →
Terminated
Class II

0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68

Lack of assurance of sterility: Potential channel leaks near the threaded vial port.

Initiated: 7/2/2015
D-1242-2015 →
Ongoing
Class II

KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49

Crystallization; identified as calcium salt of Ketorolac

Initiated: 6/30/2015
D-1241-2015 →
Ongoing
Class II

KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49

Crystallization; identified as calcium salt of Ketorolac

Initiated: 6/30/2015
D-1232-2015 →
Terminated
Class III

Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured by Hospira, Inc. 4285 Wesleyan Blvd Rocky Mount, NC 27804 for Hospira, Inc. 275 N Field Drive, Lake Forest, IL 60045. NDC 0409-2168-02

Failed pH Specifications: 12 month stability testing

Initiated: 5/19/2015
D-1216-2015 →
Terminated
Class I

Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.

Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.

Initiated: 4/23/2015
D-0972-2015 →
Terminated
Class II

Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3795-01--- Also labeled under NOVAPLUS label NDC 00409-3795-49

Crystallization

Initiated: 4/13/2015
D-0973-2015 →
Terminated
Class II

Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3796-01 --- Also labeled under NOVAPLUS label NDC 00409-3796-49

Crystallization

Initiated: 4/13/2015
D-0490-2015 →
Terminated
Class II

0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-7101-67

Lack of Sterility Assurance: The product has the potential to leak at the administrative port.

Initiated: 4/7/2015
D-1108-2015 →
Terminated
Class I

LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.

Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold

Initiated: 3/11/2015
D-1076-2015 →
Terminated
Class I

MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1.

Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.

Initiated: 3/6/2015
D-0417-2015 →
Terminated
Class II

5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045.

Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.

Initiated: 3/5/2015
D-0976-2015 →
Terminated
Class I

0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25.

Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.

Initiated: 3/5/2015
D-0483-2015 →
Terminated
Class II

KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49

Crystallization

Initiated: 1/23/2015
D-0482-2015 →
Terminated
Class II

KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49

Crystallization

Initiated: 1/23/2015
D-0969-2015 →
Terminated
Class I

0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-7983-02

Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.

Initiated: 1/20/2015
D-0381-2015 →
Terminated
Class II

Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30

Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.

Initiated: 12/23/2014
D-0334-2015 →
Terminated
Class II

0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7984-11

Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port.

Initiated: 12/22/2014
D-0433-2015 →
Terminated
Class I

MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia. Available in a) 20 mg/10 mL Multi Dose Vial (NDC: 61703-343-18); b) 25 mg/12.5 mL Multi Dose Vial (NDC: 61703-343-65); c) 30 mg/15 mL Multi Dose Vial (NDC: 61703-343-66).

Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.

Initiated: 12/3/2014
D-0294-2015 →
Terminated
Class II

Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61

Lack of Assurance of Sterility; improperly crimped fliptop vials

Initiated: 12/3/2014
D-0313-2015 →
Terminated
Class III

Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx only, Manufactured by Hospira Australia 1 Lexia Place, Mulgrave, Victoria Australia 3170. NDC 61703-327-22.

Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.

Initiated: 11/25/2014
D-0254-2015 →
Terminated
Class III

Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx only, Manufactured by Hospira, Inc. Lake Forest, IL 60045, NDC 0409-6533-01.

Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.

Initiated: 11/7/2014
D-0303-2015 →
Terminated
Class II

Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactured by Hospira Healthcare India Pvt. Ltd Tamil Nadu, India for Hospira, Inc. 275 N. Field Drive, Lake Forest, IL 60045. NDC 0409-3506-01

Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.

Initiated: 10/24/2014