Skip to content
Recall Observatory FDA recall evidence

Drug product

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

D-1106-2018

August 14, 2018

Class III

Product summary

Firm
Jubilant Cadista Pharmaceuticals, Inc.
Event
Event 80836
Status
Terminated
Classification
Class III
Quantity
7,048 bottles
Official record key
drug-enforcement:D-1106-2018

Official wording

Reason: Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

Code information: Lot #: VR417062A, Exp. 09/2019; VR417063A, VR417064A, Exp. 10/2019

Distribution pattern: Product was distributed throughout the United States to wholesalers and retailers.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.