Recalls / Class II
Class IID-0259-2019
Product
Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-223-00
- Affected lot / code info
- Lot #: HZ7896, Exp. 05/2021
Why it was recalled
Cross Contamination with Other Products
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- 7817 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-0259-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.