D-0258-2019 Class II Terminated
FDA drug recall D-0258-2019 was initiated by Sandoz Inc on November 2, 2018 and is designated Class II. Reason for recall: Cross Contamination with Other Products The recall status is terminated (terminated October 2, 2020). Affected quantity: 18,832 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 21, 2018
- Initiation Date
- November 2, 2018
- Termination Date
- October 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,832 bottles
Product Description
Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01
Reason for Recall
Cross Contamination with Other Products
Distribution Pattern
Nationwide within the United States
Code Information
Lots: a) JA9535 Exp. 05/2021.