May 2018 FDA Recall Valsartan by Jubilant Cadista Pharmaceuticals, Inc.
D-0876-2018 - Incorrect/Undeclared excipient
This Class III drug recall was voluntarily initiated by Jubilant Cadista Pharmaceuticals, Inc. on May 25, 2018 for the product Valsartan. The FDA reported the reason for recall as incorrect/undeclared excipient. The product was distributed in IN, MI, MS, NC, NJ, NY and OH and the recall is currently terminated.
Recall Number: D-0876-2018
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
05-25-2018
06-13-2018
2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A)
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Jubilant Cadista Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
IN, MI, MS, NC, NJ, NY and OH
01-08-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : VR417065A, VR417066A, Exp 10/2019
