NDC 50090-5191
valsartan 160 mg tablet
On the label: A-S Medication Solutions. It's repackaged: A-S Medication Solutions rebottles it from Jubilant Cadista Pharmaceuticals Inc.'s NDC 59746-362.
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
- A-S Medication Solutions LLC, Libertyville, IL, United States · repackages it and relabels 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, oral
- Strength
- 160 mg
- Approval
- ANDA ANDA203536
- On the market since
- Jan 5, 2015
- Package NDCs
50090-5191-050090-5191-1- Official label
- DailyMed (National Library of Medicine), updated Feb 4, 2023
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