Class II · Moderate risk
Warfarin Sodium Tablets
Failed Impurities/Degradation Specifications
Warfarin Sodium Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Content Uniformity Specifications.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only. Mfd. by: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel 26110. Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. 100 Tablet Bottle NDC: 51672-4028-1, 1000 Tablet Bottle NDC: 51672-4028-3.
Affected NDCs
51672-4028-01
51672-4028-03
Compare with the code on your package — it is the most precise check available.
Drug: Warfarin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Warfarin Sodium NDC 51672-4028 |
2 mg/1 | Tablet Oral |
Sun Pharmaceutical Industries, Inc. | Rx |
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1584-2014 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Warfarin recalls
See all
Class II · Moderate risk
Warfarin Sodium Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Warfarin Sodium Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Warfarin 2.5 ng Lactose Free Caps
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class I · High risk
Coumadin for Injection
Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials
Other recalls by Taro Pharmaceuticals U.S.A., Inc.
All 2014 recalls
Class III · Low risk
Hydrocortisone 1% & Acetic Acid 2% Otic Solution
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Class III · Low risk
Clotrimazole and Betamethasone Dipropionate Cream USP
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Class I · High risk
Clobetasol Propionate Ointment USP
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Class II · Moderate risk
Nortriptyline HCl Capsules
CGMP deviations.
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