Hospira Inc. A Pfizer Company recalls Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira,…

Recall date

February 20, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0576-2018

FDA classification

Class II

Brand / firm

Hospira Inc. A Pfizer Company

Sold / distributed

Nationwide in the USA and Puerto Rico.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.