Drug product

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

D-0876-2018

May 25, 2018

Class III

Product summary

Firm: Jubilant Cadista Pharmaceuticals, Inc.
Event: Event 80133
Status: Terminated
Classification: Class III
Quantity: 2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A)
Official record key: drug-enforcement:D-0876-2018

Official wording

Reason: Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).

Code information: Lot #: VR417065A, VR417066A, Exp 10/2019

Distribution pattern: IN, MI, MS, NC, NJ, NY and OH

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).