BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Generic: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Viona Pharmaceuticals IncManufacturer
ORALRoute
BISOPROLOL FUMARATEActive Substance
2022-11-04Original Approval
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE is FDA application ANDA215666, sponsored by CADILA. 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 II2026-01-21
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNcGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Class II2021-03-15
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count bottles, Rx Only, Distributed by: Teva PhaCGMP Deviations: Intermittent exposure to temperature excursion during storage.
Top Reported Reactions
1
HEADACHE
50 reports
2
FATIGUE
44 reports
3
DRUG INEFFECTIVE
42 reports
4
NAUSEA
41 reports
5
PRURITUS
39 reports
6
PAIN
38 reports
7
HYPERTENSION
37 reports
8
VOMITING
36 reports
9
RASH
33 reports
10
ARTHRALGIA
31 reports