Multi-event August 2018 FDA Recall Valsartan by Jubilant Cadista Pharmaceuticals, Inc.
This Multi-event Class III drug recall was voluntarily initiated by Jubilant Cadista Pharmaceuticals, Inc. on August 14, 2018 for the product Valsartan. The FDA reported the reason for recall as incorrect/undeclared excipient. The product was distributed in Product was distributed throughout the United States to wholesalers and retailers. and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1104-2018
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
08-14-2018
08-29-2018
9,552 bottles
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.
Product was distributed throughout the United States to wholesalers and retailers.
01-08-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan Tablets USP, 80 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 59746-361-90
Batch or Lot Expiration Information
Lot# : VR217013A, Exp. 08/2019
Affected Packages Involved in this Recall
Recall Number: D-1103-2018
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
08-14-2018
08-29-2018
10,577 bottles
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.
Product was distributed throughout the United States to wholesalers and retailers.
01-08-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-360-30
Batch or Lot Expiration Information
Lot# : VR117014A, VR117015A, Exp. 08/2019
Affected Packages Involved in this Recall
Recall Number: D-1105-2018
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
08-14-2018
08-29-2018
18,947 bottles
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.
Product was distributed throughout the United States to wholesalers and retailers.
01-08-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan Tablets USP, 160 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 59746-362-90
Batch or Lot Expiration Information
Lot# : VR317040A, VR317041A, VR317042A, VR317043A, Exp. 08/2019
Affected Packages Involved in this Recall
Recall Number: D-1106-2018
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
08-14-2018
08-29-2018
7,048 bottles
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.
Product was distributed throughout the United States to wholesalers and retailers.
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-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
Batch or Lot Expiration Information
Lot# : VR417062A, Exp. 09/2019; VR417063A, VR417064A, Exp. 10/2019
