RecallRadar

FDA Drug recall D-1424-2014

Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc.,…

On 2014-07-16 the FDA classified a Class II recall of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc.,… by Hospira, citing presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1424-2014
ClassificationClass II
Statusterminated
Initiated2014-05-16
Published2014-07-16
Last updated2026-09-13 11:51 UTC
CompanyHospira
DistributionUS

Product

Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-2267-20

Reason

Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution

Identifiers

ndc0409-2267-20
ndc0409-2267-54
ndc0409-0125-01
ndc0409-0125-25
code_infoLot 36225DD, exp 12/01/2015

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1424-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.