Recalls / Class II
Class IID-0258-2019
Product
Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01
- Brand name
- Isosorbide Dinitrate
- Generic name
- Isosorbide Dinitrate
- Active ingredient
- Isosorbide Dinitrate
- Route
- Oral
- NDCs
- 0781-1556, 0781-1635, 0781-1695
- FDA application
- ANDA086223
- Affected lot / code info
- Lots: a) JA9535 Exp. 05/2021.
Why it was recalled
Cross Contamination with Other Products
Recalling firm
- Firm
- Sandoz Inc
- Manufacturer
- Sandoz Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- 18,832 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2018-11-02
- FDA classified
- 2018-11-20
- Posted by FDA
- 2018-11-21
- Terminated
- 2020-10-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0258-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.