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
- Aug 8, 2018 · Class II · Hetero Labs Limited Unit V
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots: All Lots with expiration dates 7/2018 to 6/2020 - Aug 8, 2018 · Class II · Hetero Labs Limited Unit V
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots: All Lots with expiration dates 7/2018 to 6/2020 - Aug 8, 2018 · Class II · Hetero Labs Limited Unit V
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots: All Lots with expiration dates 7/2018 to 6/2020 - Aug 8, 2018 · Class II · Hetero Labs Limited Unit V
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots: All Lots with expiration dates 7/2018 to 6/2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Valsartan: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 40 mg
- Approval
- ANDA ANDA203311
- On the market since
- Jan 5, 2015
- Package NDCs
31722-745-0531722-745-3031722-745-3131722-745-3231722-745-90- 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?