Why it was recalled
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Product description
Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60
Lot numbers, UPCs & expiration codes
HC9266 4/30/2020 HD1865 4/30/2020 HP9441 9/30/2020 JK7994 8/31/2021 JK8659 8/31/2021
Where it was sold
U.S. Nationwide
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-0127-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 23, 2019
- FDA report date
- Oct 16, 2019
- Quantity
- 100,314 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz, Inc
Original FDA data
Every field from FDA enforcement report D-0127-2020, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83875
- Address
- 506 Carnegie Ctr Ste 400
- Code information
- HC9266 4/30/2020 HD1865 4/30/2020 HP9441 9/30/2020 JK7994 8/31/2021 JK8659 8/31/2021
- Postal code
- 08540-6243
- Report date
- Oct 16, 2019
- Product type
- Drugs
- Recall number
- D-0127-2020
- Classification
- Class II
- Recalling firm
- Sandoz, Inc
- Product quantity
- 100,314 bottles
- Termination date
- Jul 14, 2023
- Reason for recall
- CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Sep 23, 2019
- Initial firm notification
- Press Release
- Center classification date
- Oct 7, 2019