Hospira, Inc.

FDA Drug Class I Ongoing

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

April 21, 2017 Hospira, Inc. 71,550 syringes units

FDA Drug Class II Terminated

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

November 1, 2016 Hospira, Inc. 797,800 ampules units

FDA Drug Class II Terminated

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

August 15, 2016 Hospira, Inc. 24000 vials units

FDA Drug Class III Terminated

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

June 29, 2016 Hospira, Inc. 287,200 2 mL ampules units

FDA Drug Class II Terminated

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

June 23, 2016 Hospira, Inc. 373,850 tubes units

FDA Drug Class II Terminated

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

May 6, 2016 Hospira, Inc.

FDA Drug Class I Ongoing

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, bar

March 23, 2016 Hospira, Inc. 88,500 vials units

FDA Drug Class III Ongoing

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, bar

March 23, 2016 Hospira, Inc. 715,200 vials units

FDA Drug Class I Ongoing

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

March 18, 2016 Hospira, Inc. 72,000 units units

FDA Drug Class III Ongoing

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

March 15, 2016 Hospira, Inc. 103,600 vials units

FDA Drug Class II Terminated

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

March 8, 2016 Hospira, Inc. 552 bags units

FDA Drug Class II Terminated

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

March 8, 2016 Hospira, Inc. 22292 bags units

FDA Drug Class II Terminated

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

March 8, 2016 Hospira, Inc. 4368 bags units

FDA Drug Class II Terminated

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

March 8, 2016 Hospira, Inc. 11256 bags units

FDA Drug Class II Terminated

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

March 8, 2016 Hospira, Inc. 81888 bags units

FDA Drug Class II Terminated

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

March 8, 2016 Hospira, Inc. 1776 bags units

FDA Drug Class III Ongoing

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 (0

February 2, 2016 Hospira, Inc. 10,778 bags units

FDA Drug Class I Terminated

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.

January 5, 2016 Hospira, Inc. 213,600 bags units

FDA Drug Class III Ongoing

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

September 29, 2015 Hospira, Inc. 24,100 Syringes units

FDA Drug Class II Ongoing

1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-4279-02

August 25, 2015 Hospira, Inc. 100,200 Vials units

FDA Drug Class II Terminated

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

August 20, 2015 Hospira, Inc. 83,320 vials units

FDA Drug Class II Terminated

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

July 2, 2015 Hospira, Inc. 314600 bags units

FDA Drug Class II Ongoing

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

June 30, 2015 Hospira, Inc. 12,460,975 vials(Hospira label); 3,016,500 vials (NOVAPLUS label) units

FDA Drug Class II Ongoing

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

June 30, 2015 Hospira, Inc. 5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label) units

FDA Drug Class III Terminated

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

May 19, 2015 Hospira, Inc. 106,900 vials units

FDA Drug Class I Terminated

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.

April 23, 2015 Hospira, Inc. 150,950 Vials units

FDA Drug Class II Terminated

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

April 13, 2015 Hospira, Inc.

FDA Drug Class II Terminated

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

April 13, 2015 Hospira, Inc.

FDA Drug Class II Terminated

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

April 7, 2015 Hospira, Inc. 128,050 ADD-Vantage flexible containers units

FDA Drug Class I Terminated

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

March 11, 2015 Hospira, Inc. 24,744 flexible container bags units

FDA Drug Class I Terminated

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.

March 6, 2015 Hospira, Inc. 181,704 bags units

FDA Drug Class I Terminated

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

March 5, 2015 Hospira, Inc. 9,912 VisIV flex containers units

FDA Drug Class II Terminated

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, Hospi

March 5, 2015 Hospira, Inc. 94,440 bags units

FDA Drug Class II Terminated

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

January 23, 2015 Hospira, Inc. HOSPIRA = 13,720,475 vials, NOVAPLUS = 1,528,500 vials units

FDA Drug Class II Terminated

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

January 23, 2015 Hospira, Inc. HOSPIRA = 4,339,500 vials. NOVAPLUS = 341,100 vials units

FDA Drug Class I Terminated

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

January 20, 2015 Hospira, Inc. 661,128 containers units

FDA Drug Class II Terminated

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

December 23, 2014 Hospira, Inc. 126,075 vials units

FDA Drug Class II Terminated

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

December 22, 2014 Hospira, Inc. 30840 bags units

FDA Drug Class II Terminated

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

December 3, 2014 Hospira, Inc. 62,650 vials units

FDA Drug Class I Terminated

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 Mu

December 3, 2014 Hospira, Inc. 13,792 Vials (U.S.) units

FDA Drug Class III Terminated

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.

November 25, 2014 Hospira, Inc. 3,306 vials units

FDA Drug Class III Terminated

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.

November 7, 2014 Hospira, Inc. 316,640 vials units

FDA Drug Class II Terminated

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

October 24, 2014 Hospira, Inc. 261,706 vials units

FDA Drug Class I Terminated

1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, Hospira, Inc., Lake Forest, IL 6

October 16, 2014 Hospira, Inc. 100,100 units units

FDA Drug Class II Terminated

5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7941-09.

October 14, 2014 Hospira, Inc. 340,272 bags units

FDA Drug Class II Terminated

0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.

October 14, 2014 Hospira, Inc. 784,920 bags units

FDA Drug Class II Terminated

Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7990-09.

October 14, 2014 Hospira, Inc. 153,504 bags units

FDA Drug Class II Terminated

0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.

October 14, 2014 Hospira, Inc. 16,487,040 bags units

FDA Drug Class II Terminated

5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7922-09.

October 14, 2014 Hospira, Inc. 301,560 bags units

FDA Drug Class II Terminated

5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-09.

October 14, 2014 Hospira, Inc. 823,296 bags units