FDAFDA · Food and drugs·Recall number D-1106-2018
Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-363-90
Published August 29, 2018 · Recall initiated: August 14, 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: There is a potential an incorrect grade of excipient was used during manufacturing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Distributor
- Product was distributed throughout the United States to wholesalers and retailers.
- Lot
- Lot #: VR417062A, Exp. 09/2019; VR417063A, VR417064A, Exp. 10/2019
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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