Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01
Lot numbers, UPCs & expiration codes
Batch #: NB101596, Exp. 04/30/2023
Where it was sold
Product was distributed to 16 distributors and 8 wholesalers who may have further distributed the product 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-0348-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 15, 2023
- FDA report date
- Mar 1, 2023
- Quantity
- 12,216 bottles (100 count each)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RISING PHARMACEUTICALS
Original FDA data
Every field from FDA enforcement report D-0348-2023, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 91713
- Address
- 2 Tower Center Blvd
- Code information
- Batch #: NB101596, Exp. 04/30/2023
- Postal code
- 08816-1100
- Report date
- Mar 1, 2023
- Product type
- Drugs
- Recall number
- D-0348-2023
- Classification
- Class II
- Recalling firm
- RISING PHARMACEUTICALS
- Product quantity
- 12,216 bottles (100 count each)
- Termination date
- Jun 14, 2024
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01
- Distribution pattern
- Product was distributed to 16 distributors and 8 wholesalers who may have further distributed the product nationwide.
- Recall initiation date
- Feb 15, 2023
- Initial firm notification
- Letter
- Center classification date
- Feb 23, 2023