Why it was recalled
Cross Contamination with Other Products
Product description
Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00
Lot numbers, UPCs & expiration codes
Lot #: JA9534, Exp. 05/2021
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0261-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 2, 2018
- FDA report date
- Nov 21, 2018
- Quantity
- 1550 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-0261-2019, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81457
- Address
- 100 College Rd W
- Code information
- Lot #: JA9534, Exp. 05/2021
- Postal code
- 08540-6604
- Report date
- Nov 21, 2018
- Product type
- Drugs
- Recall number
- D-0261-2019
- Classification
- Class II
- Recalling firm
- Sandoz Inc
- Product quantity
- 1550 bottles
- Termination date
- Oct 2, 2020
- Reason for recall
- Cross Contamination with Other Products
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Nov 2, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 20, 2018