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Recall Observatory FDA recall evidence

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

February 15, 2023

Class II

Product summary

Firm
RISING PHARMACEUTICALS
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

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications