Taro Recalls Warfarin Sodium Tablets Due to Content Uniformity Failures
Taro Pharmaceuticals is recalling specific lots of Warfarin Sodium tablets because they failed content uniformity specifications. The affected products were distributed in seven US states.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class III recall, which indicates a remote possibility of adverse health consequences. The hazard is a quality specification failure (content uniformity) without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk contamination or specification deviations.
Plain-English summary
Taro Pharmaceuticals U.S.A., Inc. is recalling 1,396 bottles of Warfarin Sodium Tablets, USP Crystalline, 2 mg. The recall involves 100-tablet and 1,000-tablet bottles manufactured by Taro Pharmaceutical Industries, Ltd. in Israel and distributed by Taro Pharmaceuticals U.S.A., Inc. in Hawthorne, NY.
The recall was initiated because the affected products failed content uniformity specifications. This means the amount of active ingredient in the tablets may not be consistent throughout the bottle, which could affect the medication's efficacy or safety profile.
The affected lots are 149400 and 149649, both with an expiration date of January 2016. The products were distributed in the United States, specifically in Ohio, Hawaii, New Hampshire, Mississippi, Illinois, Texas, and California. Patients and healthcare providers should stop using the affected lots and contact their healthcare provider for guidance on alternative treatment or replacement medication.
The recalled product
- Product
- WARFARIN SODIUM (WARFARIN SODIUM)
- Brand
- WARFARIN SODIUM
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Category
- Drug — Anticoagulant
- Hazard
- Affected units
- 1,396
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 (4)
- Lot #: 149400
- Expiry: January 2016
- Lot #: 149649
- Expiry: January 2016.
UPCs (8)
- 0351672402815
- 0351672403416
- 0351672402914
- 0351672403119
- 0351672403218
- 0351672403010
- 0351672403515
- 0351672403317
Distribution
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