VENLAFAXINE HYDROCHLORIDE

Generic: VENLAFAXINE HYDROCHLORIDE

Sun Pharmaceutical IndustriesManufacturer

ORALRoute

VENLAFAXINE HYDROCHLORIDEActive Substance

2010-08-18Original Approval

VENLAFAXINE HYDROCHLORIDE is FDA application ANDA091272, sponsored by SUN PHARM. 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 6838

Failed Dissolution Specifications: out of specification dissolution results in retained samples

Class II2025-03-21

Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydu

Presence of Foreign Substance: Product complaint received for the presence of foreign material embed

Class II2016-12-22

Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pha

Failed 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 68382

Failed Dissolution Specifications: out of specification dissolution results in retained samples

Class II2013-03-05

Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd

Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or c

Class III2016-03-25

Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (

Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release table

Class III2025-01-16

Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.

Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet

VENLAFAXINE HYDROCHLORIDE

Recalls

Top Reported Reactions