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.

Recall Number: D-0576-2018

Firm: Hospira Inc. A Pfizer Company

Classification: Class II

Status: Terminated

Report Date: 20180314

Initiation Date: 20180220

Termination Date: 20200402

Reason for Recall

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

Product Description

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.