NDC 45865-101
valsartan 80 mg tablet
On the label: Medsource Pharmaceuticals. It's repackaged: Medsource Pharmaceuticals rebottles it from Jubilant Cadista Pharmaceuticals Inc.'s NDC 59746-361.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Jubilant Generics Limited | Roorkee, India | Makes it | Problems found, fixed voluntarilyFeb 2, 2024 · 8 inspections, 3 with FDA action |
Repackaging site
- Medsource Pharmaceuticals, Rancho Santa Margarita, CA, United States · repackages it
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: VR120022A - Aug 14, 2018 · Class III · Jubilant Cadista Pharmaceuticals, Inc.
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Lots: Lot #: VR117014A, VR117015A, Exp. 08/2019 - Aug 14, 2018 · Class III · Jubilant Cadista Pharmaceuticals, Inc.
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Lots: Lot #: VR217013A, Exp. 08/2019 - Aug 14, 2018 · Class III · Jubilant Cadista Pharmaceuticals, Inc.
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Lots: Lot #: VR317040A, VR317041A, VR317042A, VR317043A, Exp. 08/2019
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Valsartan: every company that makes it
- Form
- tablet
- Strength
- 80 mg
- Approval
- ANDA ANDA203536
- On the market since
- Jul 3, 2020
- Package NDCs
45865-101-60- Official label
- DailyMed (National Library of Medicine), updated Dec 27, 2020
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