Drug 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
D-0348-2023
Product summary
- Event
- Event 91713
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,216 bottles (100 count each)
- Official record key
drug-enforcement:D-0348-2023
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Batch #: NB101596, Exp. 04/30/2023
Distribution pattern: Product was distributed to 16 distributors and 8 wholesalers who may have further distributed the product nationwide.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications