Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hetero Labs Limited | Mahabubnagar, India | Makes it | Problems found, fixed voluntarilyAug 12, 2022 · 5 inspections, 1 with FDA action |
Recalls
- Jul 20, 2017 · Class II · Hetero USA Inc
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Lots: Lot # ENT17008, Exp 01/2019
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Entecavir: every company that makes it
- Form
- tablet, oral
- Strength
- 1 mg
- Approval
- ANDA ANDA205740
- On the market since
- Aug 21, 2015
- Package NDCs
31722-834-3031722-834-3131722-834-3231722-834-90- Official label
- DailyMed (National Library of Medicine), updated Jan 9, 2025
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?