NDC 53217-194

venlafaxine hydrochloride 150 mg capsule, extended release

On the label: Aidarex Pharmaceuticals LLC. It's repackaged: Aidarex Pharmaceuticals LLC rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-036.

Where the pills inside were made

Factory	Where	Role	Last FDA inspection
Zydus Lifesciences Limited	Ahmedabad, India	Makes it and tests it	Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action

Jun 21, 2024 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Lots: Lot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024
Jul 19, 2016 · Class II · Zydus Pharmaceuticals USA Inc
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Lots: Lot #: a) MR10518, Exp. 9/2017; MR11051, MR11052, MR11053, MR11054, Exp. 10/2017; MR11403, Exp. 11/2017. Lot #: b) MR10197, MR10195, Exp. 09/2017; MR11482, Exp.10/2017; MR11479, MR11480, MR11481, MR11483, MR11665 Exp. 11/2017. Lot #: c) MR10404, MR10406, MR10521, Exp. 09/2017; MR10744, MR1105…
Jul 19, 2016 · Class II · Zydus Pharmaceuticals USA Inc
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Lots: Lot #: a) MS1217, MS1218 , Exp.12/2017. Lot #: b) MS1215, Exp.12/2017 Lot #: c) MR11150, MR11151, MR11854, Exp. 10/2017; MR11798, MR11799, MS1214, Exp.11/2017

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Generic drug: Venlafaxine: every company that makes it
Form: capsule, extended release
Strength: 150 mg
Approval: ANDA ANDA090174
On the market since: Jun 1, 2011
Package NDCs: 53217-194-01 53217-194-05 53217-194-30 53217-194-60 53217-194-90 53217-194-93
Official label: DailyMed (National Library of Medicine), updated Jun 23, 2016

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