D-1106-2018 Class III Terminated
FDA drug recall D-1106-2018 was initiated by Jubilant Cadista Pharmaceuticals, Inc. on Aug 14, 2018 and is designated Class III. Reason for recall: Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing. The recall status is terminated (terminated Jan 8, 2020). Affected quantity: 7,048 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 29, 2018
- Initiation Date
- Aug 14, 2018
- Termination Date
- Jan 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,048 bottles
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
Reason for Recall
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Distribution Pattern
Product was distributed throughout the United States to wholesalers and retailers.
Code Information
Lot #: VR417062A, Exp. 09/2019; VR417063A, VR417064A, Exp. 10/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1106-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026