Recalls / Class II
Class IID-0348-2023
Product
Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01
- Affected lot / code info
- Batch #: NB101596, Exp. 04/30/2023
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- RISING PHARMACEUTICALS
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Tower Center Blvd, N/A, East Brunswick, New Jersey 08816-1100
Distribution
- Quantity
- 12,216 bottles (100 count each)
- Distribution pattern
- Product was distributed to 16 distributors and 8 wholesalers who may have further distributed the product nationwide.
Timeline
- Recall initiated
- 2023-02-15
- FDA classified
- 2023-02-23
- Posted by FDA
- 2023-03-01
- Terminated
- 2024-06-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0348-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.