Hospira Inc., A Pfizer Company

FDA Drug Class II Terminated

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 H

February 20, 2018 Hospira Inc., A Pfizer Company a) 137,975 vials; b) 40,143 vials units

FDA Drug Class III Terminated

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 6004

July 6, 2017 Hospira Inc., A Pfizer Company 701 vials units

FDA Drug Class II Terminated

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

May 18, 2017 Hospira Inc., A Pfizer Company (720503A): 43,200 vials, (720603A): 400 vials units

FDA Drug Class II Terminated

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

February 10, 2017 Hospira Inc., A Pfizer Company 578,784 bags units

FDA Drug Class I Terminated

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 04

January 24, 2017 Hospira Inc., A Pfizer Company 30,880 vials units

FDA Drug Class II Terminated

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.

September 16, 2016 Hospira Inc., A Pfizer Company 4768 vials units

FDA Drug Class II Terminated

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.

September 16, 2016 Hospira Inc., A Pfizer Company 15 vials units

FDA Drug Class I Ongoing

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

August 4, 2016 Hospira Inc., A Pfizer Company 143,250 vials units