Reported Aug 29, 2018 · Terminated
Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India,…
Jubilant Cadista Pharmaceuticals, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Jubilant Cadista Pharmaceuticals, Inc. · 207 Kiley Dr · Salisbury, MD · 21801-2249
Is this the product you have?
- Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only
- Manufactured byJubilant Generics Ltd Roorkee 0247661 India
- Marketed byJubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-361-90
- Lot codes and dates
Lot #: VR217013AExp. 08/2019
- Amount recalled
- 9,552 bottles
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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