FDA recall D-0576-2018

Product

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.

Reason for recall

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

Distribution

Nationwide in the USA and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2018-02-20

Report date

2018-03-14

Termination date

2020-04-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mcpherson, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0576-2018