NDC 68382-034
venlafaxine hydrochloride 37.5 mg capsule, extended release
On the label: Zydus Pharmaceuticals (USA) Inc..
Where it's 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 |
Recalls
- 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.
Product details
- Generic drug
- Venlafaxine: every company that makes it
- Form
- capsule, extended release, oral
- Strength
- 37.5 mg
- Approval
- ANDA ANDA090174
- On the market since
- Jun 1, 2011
- Package NDCs
68382-034-0668382-034-1068382-034-16- Official label
- DailyMed (National Library of Medicine), updated Oct 21, 2022
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