Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07... — FDA record D-0348-2023

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 15, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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
Failed Impurities/Degradation Specifications
Classification
Class II
Recalling firm
RISING PHARMACEUTICALS
Quantity
12,216 bottles (100 count each)
Agency-reported status
Terminated
Source record identifier
D-0348-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityBatch #: NB101596, Exp. 04/30/2023

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Product was distributed to 16 distributors and 8 wholesalers who may have further distributed the product nationwide.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Mar 1, 2023
Recall initiation date
Feb 15, 2023
Center classification date
Feb 23, 2023
Termination date
Jun 14, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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