Manufacturers/Hospira Inc.

Hospira Inc.

119 drugs in NADAC|117 Generic,2 Brand

View Recalls (50)

Total Drugs

119

117G / 2B

Avg Price / Unit

$4.3185

$0.02 – $43.35

Avg 7d Change

+0.88%

Across 57 drugs with changes

7d Activity

342362 flat

of 119 total drugs

Portfolio Price Trend

Monthly average NADAC price across all drugs

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
$28.3961
per EA
+5.82%
BLEOMYCIN SULFATE 15 UNIT VIAL
BLEOMYCIN
$26.4480
per EA
+4.84%
BLEOMYCIN SULFATE 15 UNIT VIAL
BLEOMYCIN
$26.4480
per EA
+4.84%
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 SYRINGE
NALOXONE HYDROCHLORIDE
$15.2708
per ML
DAPTOMYCIN 350 MG VIAL
DAPTOMYCIN
$13.4180
per EA
TESTOSTERONE CYP 200 MG/ML
testosterone cypionate
$11.4488
per ML
+0.01%
TAZICEF 2 GRAM VIAL
CEFTAZIDIME
$9.5080
per EA
VANCOMYCIN 1 GM ADD-VAN VIAL
VANCOMYCIN HYDROCHLORIDE
$6.4880
per EA
MEROPENEM IV 1 GM VIAL
Meropenem
$5.5712
per EA
-4.57%
MEROPENEM IV 1 GM VIAL
Meropenem
$5.5712
per EA
-4.57%
TESTOSTERONE CYP 1,000 MG/10 ML
testosterone cypionate
$5.5487
per ML
-1.66%
CEFEPIME HCL 2 GRAM VIAL
Cefepime
$5.3480
per EA
DIAZEPAM 5 MG/ML SYRINGE
DIAZEPAM
$5.2875
per ML
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
$4.2587
per ML
+4.14%
TAZICEF 1 GRAM VIAL
CEFTAZIDIME
$3.7508
per EA
CEFEPIME HCL 1 GM VIAL
Cefepime
$3.7308
per EA
METHOTREXATE 50 MG/2 ML VIAL
Methotrexate
$3.3484
per ML
-0.31%
METHOTREXATE 50 MG/2 ML VIAL
Methotrexate
$3.3484
per ML
-0.31%
METHOTREXATE 50 MG/2 ML VIAL
Methotrexate
$3.3484
per ML
-0.31%
TESTOSTERONE CYP 2,000 MG/10 ML
testosterone cypionate
$3.2641
per ML
+0.14%
HYDROMORPHONE 2 MG/ML CARPUJCT
HYDROMORPHONE HYDROCHLORIDE
$3.2446
per ML
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
$2.5922
per EA
+2.32%
CEFTRIAXONE 2 GM VIAL
Ceftriaxone Sodium
$2.5922
per EA
+2.32%
HYDROMORPHONE 50 MG/5 ML VIAL
Hydromorphone Hydrochloride
$2.5663
per ML
+1.67%
HYDROMORPHONE 500 MG/50 ML VIAL
Hydromorphone Hydrochloride
$2.5663
per ML
+1.67%
VANCOMYCIN 500 MG VIAL
VANCOMYCIN HYDROCHLORIDE
$2.3054
per EA
HEPARIN SODIUM 10,000 UNIT/ML VIAL
HEPARIN SODIUM
$2.2868
per ML
-1.61%
PACLITAXEL 30 MG/5 ML VIAL
PACLITAXEL
$2.1290
per ML
PACLITAXEL 100 MG/16.7 ML VIAL
PACLITAXEL
$1.8891
per ML
MORPHINE 2 MG/ML CARPUJECT
MORPHINE SULFATE
$1.8340
per ML
PACLITAXEL 300 MG/50 ML VIAL
PACLITAXEL
$1.7700
per ML
MORPHINE 10 MG/ML CARPUJECT
MORPHINE SULFATE
$1.5952
per ML
KETAMINE 500 MG/5 ML VIAL
Ketamine Hydrochloride
$1.5655
per ML
+0.13%
KETAMINE 500 MG/5 ML VIAL
KETAMINE HYDROCHLORIDE
$1.5655
per ML
+0.13%
GENTAMICIN 80 MG/2 ML VIAL
GENTAMICIN SULFATE
$1.4501
per ML
-5.35%
CEFTRIAXONE 1 GM VIAL
Ceftriaxone Sodium
$1.3400
per EA
-0.02%
CEFTRIAXONE 1 GM VIAL
Ceftriaxone Sodium
$1.3400
per EA
-0.02%
FENTANYL 100 MCG/2 ML VIAL
FENTANYL CITRATE
$1.2480
per ML
+1.02%
EPINEPHRINE 1 MG/10 ML ABBOJCT
epinephrine
$1.1910
per ML
-0.95%
HEPARIN SODIUM 5,000 UNIT/ML VIAL
HEPARIN SODIUM
$1.1361
per ML
+1.21%
MIDAZOLAM HCL 5 MG/ML VIAL
MIDAZOLAM HYDROCHLORIDE
$1.1025
per ML
+6.07%
MIDAZOLAM HCL 5 MG/ML VIAL
MIDAZOLAM HYDROCHLORIDE
$1.1025
per ML
+6.07%
CARBOPLATIN 150 MG/15 ML VIAL
Carboplatin
$0.9933
per ML
CEFTRIAXONE 500 MG VIAL
Ceftriaxone Sodium
$0.9894
per EA
+6.01%
CEFTRIAXONE 500 MG VIAL
Ceftriaxone Sodium
$0.9894
per EA
+6.01%
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
KETOROLAC 30 MG/ML VIAL
KETOROLAC TROMETHAMINE
$0.7389
per ML
+4.85%
ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$0.6997
per ML
-1.99%
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
$0.6417
per ML
-0.20%
TOBRAMYCIN 80 MG/2 ML VIAL
TOBRAMYCIN
$0.6294
per ML
+4.97%
MIDAZOLAM HCL 10 MG/2 ML VIAL
MIDAZOLAM HYDROCHLORIDE
$0.5545
per ML
-1.37%
MIDAZOLAM HCL 10 MG/2 ML VIAL
MIDAZOLAM HYDROCHLORIDE
$0.5545
per ML
-1.37%
KETAMINE 500 MG/10 ML VIAL
Ketamine Hydrochloride
$0.5215
per ML
+0.03%
METOCLOPRAMIDE 10 MG/2 ML VIAL
metoclopramide
$0.5198
per ML
+0.09%
METOCLOPRAMIDE 10 MG/2 ML VIAL
metoclopramide
$0.5198
per ML
+0.09%
METOCLOPRAMIDE 10 MG/2 ML VIAL
metoclopramide
$0.5198
per ML
+0.09%
METOCLOPRAMIDE 10 MG/2 ML VIAL
metoclopramide
$0.5198
per ML
+0.09%
KETOROLAC 60 MG/2 ML VIAL
KETOROLAC TROMETHAMINE
$0.5086
per ML
+6.29%
KETOROLAC 60 MG/2 ML VIAL
KETOROLAC TROMETHAMINE
$0.5086
per ML
+6.29%
LIDOCAINE HCL 2% SYRINGE
LIDOCAINE HYDROCHLORIDE
$0.4706
per ML
MIDAZOLAM HCL 50 MG/10 ML VIAL
MIDAZOLAM HYDROCHLORIDE
$0.4500
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
FUROSEMIDE 20 MG/2 ML VIAL
FUROSEMIDE
$0.4049
per ML
+1.74%
FUROSEMIDE 20 MG/2 ML VIAL
FUROSEMIDE
$0.4049
per ML
+1.74%
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
LIDOCAINE HCL 2% 100 MG/5 ML
Lidocaine Hydrochloride
$0.3581
per ML
-4.42%
FUROSEMIDE 40 MG/4 ML VIAL
FUROSEMIDE
$0.3500
per ML
+1.55%
FUROSEMIDE 40 MG/4 ML VIAL
FUROSEMIDE
$0.3500
per ML
+1.55%
SODIUM BICARB 8.4% ABBOJECT
Sodium Bicarbonate
$0.3288
per ML
WATER FOR INJECTION VIAL
WATER
$0.3188
per ML
-0.54%
WATER FOR INJECTION VIAL
WATER
$0.3188
per ML
-0.54%
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
ONDANSETRON HCL 4 MG/2 ML VIAL
ONDANSETRON
$0.1864
per ML
-1.45%
ONDANSETRON HCL 4 MG/2 ML VIAL
ONDANSETRON
$0.1864
per ML
-1.45%
PROPOFOL 200 MG/20 ML VIAL
PROPOFOL
$0.1750
per ML
ONDANSETRON 40 MG/20 ML VIAL
ONDANSETRON
$0.1585
per ML
-4.37%
SODIUM BICARBONATE 8.4% VIAL
SODIUM BICARBONATE
$0.1540
per ML
SODIUM BICARBONATE 8.4% VIAL
SODIUM BICARBONATE
$0.1540
per ML
BACTERIOSTATIC WATER VIAL
Bacteriostatic Water
$0.1495
per ML
+5.55%
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
$0.0888
per ML
+1.01%
SODIUM CHLORIDE 0.9% VIAL
Sodium Chloride
$0.0888
per ML
+1.01%
LIDOCAINE 1%-EPI 1:100,000
LIDOCAINE HYDROCHLORIDE and EPINEPHRINE
$0.0883
per ML
LIDOCAINE HCL 2% VIAL
LIDOCAINE HYDROCHLORIDE
$0.0859
per ML
-2.75%
LIDOCAINE HCL 1% VIAL
LIDOCAINE HYDROCHLORIDE
$0.0755
per ML
-1.00%
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
$0.0397
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