Valsartan Tablet
FDA Recall NDC 59746-362
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 6 recorded enforcement report(s) associated with Valsartan (NDC 59746-362). A significant event, classified as Class II, was initiated on Mar 15, 2021 by Jubilant Cadista Pharmacuticals Inc.. The reported reason for this action was: "CGMP Deviations: Intermittent exposure to temperature excursion during storage."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
20 bottles
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by: Jubilant Generics Ltd. Roorkee-247661, India
Batch or Lot Expiration Information
Lot# VR120022A
Affected Packages Involved in this Recall
59746-360-30Product
59746-360-90Product
59746-360-05Product
59746-360-03Product
59746-361-30Product
59746-361-90Product
59746-361-05Product
59746-361-03Product
59746-362-30Product
59746-362-90Product
59746-362-05Product
59746-362-03Product
59746-363-30Product
59746-363-90Product
59746-363-67Product
59746-363-32Product
Class III Terminated
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Aug 14, 2018
Aug 29, 2018
9,552 bottles
Recall Profile & Regulatory Data
Event ID
80836
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Jubilant Cadista Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States to wholesalers and retailers.
Termination Date
Jan 08, 2020
Product Description
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
59746-360-30Product
59746-360-90Product
59746-360-05Product
59746-360-03Product
59746-361-30Product
59746-361-90Product
59746-361-05Product
59746-361-03Product
59746-362-30Product
59746-362-90Product
59746-362-05Product
59746-362-03Product
59746-363-30Product
59746-363-90Product
59746-363-67Product
59746-363-32Product
Class III Terminated
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Aug 14, 2018
Aug 29, 2018
10,577 bottles
Recall Profile & Regulatory Data
Event ID
80836
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Jubilant Cadista Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States to wholesalers and retailers.
Termination Date
Jan 08, 2020
Product Description
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
59746-360-30Product
59746-360-90Product
59746-360-05Product
59746-360-03Product
59746-361-30Product
59746-361-90Product
59746-361-05Product
59746-361-03Product
59746-362-30Product
59746-362-90Product
59746-362-05Product
59746-362-03Product
59746-363-30Product
59746-363-90Product
59746-363-67Product
59746-363-32Product
Class III Terminated
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Aug 14, 2018
Aug 29, 2018
18,947 bottles
Recall Profile & Regulatory Data
Event ID
80836
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Jubilant Cadista Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States to wholesalers and retailers.
Termination Date
Jan 08, 2020
Product Description
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
59746-360-30Product
59746-360-90Product
59746-360-05Product
59746-360-03Product
59746-361-30Product
59746-361-90Product
59746-361-05Product
59746-361-03Product
59746-362-30Product
59746-362-90Product
59746-362-05Product
59746-362-03Product
59746-363-30Product
59746-363-90Product
59746-363-67Product
59746-363-32Product
Class III Terminated
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Aug 14, 2018
Aug 29, 2018
7,048 bottles
Recall Profile & Regulatory Data
Event ID
80836
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Jubilant Cadista Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States to wholesalers and retailers.
Termination Date
Jan 08, 2020
Product Description
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
Affected Packages Involved in this Recall
59746-360-30Product
59746-360-90Product
59746-360-05Product
59746-360-03Product
59746-361-30Product
59746-361-90Product
59746-361-05Product
59746-361-03Product
59746-362-30Product
59746-362-90Product
59746-362-05Product
59746-362-03Product
59746-363-30Product
59746-363-90Product
59746-363-67Product
59746-363-32Product
Class III Terminated
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
May 25, 2018
Jun 13, 2018
2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A)
Recall Profile & Regulatory Data
Event ID
80133
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Jubilant Cadista Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
IN, MI, MS, NC, NJ, NY and OH
Termination Date
Jan 08, 2020
Product Description
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
Affected Packages Involved in this Recall
59746-360-30Product
59746-360-90Product
59746-360-05Product
59746-360-03Product
59746-361-30Product
59746-361-90Product
59746-361-05Product
59746-361-03Product
59746-362-30Product
59746-362-90Product
59746-362-05Product
59746-362-03Product
59746-363-30Product
59746-363-90Product
59746-363-67Product
59746-363-32Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
