Warfarin Sodium Tablets Recalled Due to Failed Impurity and Degradation Specifications
Rising Pharmaceuticals is recalling Warfarin Sodium Tablets USP 1 mg due to failed impurities and degradation specifications. Approximately 12,216 bottles may have been distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II pharmaceutical recall triggered by failure to meet product quality specifications for impurities and degradation. No illnesses or injuries are reported in the source material, making this a quality/specification failure without evidence of harm.
Plain-English summary
Rising Pharmaceuticals is recalling Warfarin Sodium Tablets, USP 1 mg (NDC# 57237-119-01) distributed by Rising Health, LLC, Saddle Brook, NJ. The recall affects approximately 12,216 bottles (100-count each) from batch NB101596, with an expiration date of April 30, 2023. The product was distributed to 16 distributors and 8 wholesalers, which may have further distributed it nationwide.
The tablets are being recalled because they failed specifications for impurities and degradation.
Patients who have received this medication should contact their pharmacy or healthcare provider to determine if their supply was affected.
The recalled product
- 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
- Manufacturer
- RISING PHARMACEUTICALS
- Category
- Drug — Prescription medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch #: NB101596
- Exp. 04/30/2023
Distribution
Distributed nationwide across the United States.
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