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, I
Recalled March 14, 2018 · FDA recall D-0576-2018 · Hospira Inc. A Pfizer
Hazard
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal. · FDA Class II
Units
a) 137,975 vials; b) 40,143 vials
Sold at
Nationwide in the USA and Puerto Rico.
Description
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
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.
Manufacturer(s)
Hospira Inc. A Pfizer Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →