FDA-Drug2023-03-01Class II

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

RISING PHARMACEUTICALS
Hazard

Failed Impurities/Degradation Specifications

Sold states
Product was distributed to 16 distributors and 8 wholesalers who may have further distributed the product nationwide.
Affected count
12,216 bottles (100 count each)
Manufactured in
2 Tower Center Blvd, N/A, East Brunswick, NJ, United States
Products
Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0348-2023

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