FDAFDA · Food and drugs·Recall number D-0876-2018
Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90
Published June 13, 2018 · Recall initiated: May 25, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Distributor
- IN, MI, MS, NC, NJ, NY and OH
- Lot
- Lot #: VR417065A, VR417066A, Exp 10/2019
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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