VENLAFAXINE HYDROCHLORIDE
Generic: VENLAFAXINE
XLCare PharmaceuticalsManufacturer
ORALRoute
VENLAFAXINE HYDROCHLORIDEActive Substance
2020-10-21Original Approval
VENLAFAXINE HYDROCHLORIDE is FDA application ANDA214419, sponsored by ASCENT PHARMS INC. 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 II2016-07-19
Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 6838Failed Dissolution Specifications: out of specification dissolution results in retained samples
Class II2016-12-22
Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo PhaFailed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsule
Class II2024-06-21
Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at
Class II2016-07-19
Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382Failed Dissolution Specifications: out of specification dissolution results in retained samples
Top Reported Reactions
1
DRUG INEFFECTIVE
5,764 reports
2
NAUSEA
4,563 reports
3
TOXICITY TO VARIOUS AGENTS
4,441 reports
4
OFF LABEL USE
4,431 reports
5
FATIGUE
4,358 reports
6
HEADACHE
3,902 reports
7
COMPLETED SUICIDE
3,326 reports
8
DRUG INTERACTION
3,236 reports
9
DIZZINESS
3,133 reports
10
DIARRHOEA
2,901 reports