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.