Status
Terminated
Drug Enforcement D-0348-2023
Failed Impurities/Degradation Specifications
Classification
Class II
Report Date
March 1, 2023
Termination Date
June 14, 2024
Product Information
- 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
- Product quantity
- 12,216 bottles (100 count each)
- Reason for recall
- Failed Impurities/Degradation Specifications
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed to 16 distributors and 8 wholesalers who may have further distributed the product nationwide.
Location & Firm
- Recalling firm
- RISING PHARMACEUTICALS
- Address
-
2 Tower Center Blvd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0348-2023
- Event ID
- 91713
- Recall initiation date
- February 15, 2023
- Center classification date
- February 23, 2023
- Code info
- Batch #: NB101596, Exp. 04/30/2023
- More code info
- —