Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01

FDA recall notice · announced March 1, 2023 · Rising Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Failed Impurities/Degradation Specifications

Notes

Distribution: Product was distributed to 16 distributors and 8 wholesalers who may have further distributed the product nationwide.
Lot/code information: Batch #: NB101596, Exp. 04/30/2023
Quantity: 12,216 bottles (100 count each)
Status: Terminated
Products in this recall event:
- Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01 (D-0348-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.