LABETALOL HYDROCHLORIDE

Generic: LABETALOL HYDROCHLORIDE, LABETALOL

Method PharmaceuticalsManufacturer
ORALRoute
LABETALOLActive Substance
1999-07-29Original Approval

LABETALOL HYDROCHLORIDE is FDA application ANDA075215, sponsored by INNOGENIX. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2024-05-20
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Lu

Lack of Assurance of Sterility-The potential for incomplete crimp seals.

Top Reported Reactions

1
DRUG INEFFECTIVE
1,036 reports
2
MATERNAL EXPOSURE DURING PREGNANCY
975 reports
3
FOETAL EXPOSURE DURING PREGNANCY
953 reports
4
HYPERTENSION
750 reports
5
PREMATURE BABY
735 reports
6
OFF LABEL USE
706 reports
7
EXPOSURE DURING PREGNANCY
657 reports
8
CHRONIC KIDNEY DISEASE
645 reports
9
ACUTE KIDNEY INJURY
642 reports
10
FATIGUE
600 reports