Reported Jun 13, 2018 · Terminated
Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, 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, 320 mg, 90 tablet, Rx Only
- Manufactured byJubilant Generics Ltd. Roorkee - 247661, India
- Marketed byJubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90
- Lot codes and dates
Lot #: VR417065AVR417066AExp 10/2019
- Amount recalled
- 2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A)
Where it was sold
Why it was recalled
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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