Zydus Recalls Warfarin Sodium Tablets Due to Oversized Pills
Zydus Pharmaceuticals is recalling 960 bottles of Warfarin Sodium Tablets 2 mg because a pharmacist found three oversized tablets in one bottle.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling 960 bottles of Warfarin Sodium Tablets, USP 2 mg (NDC 68382-053-10). The product is distributed nationwide and was manufactured by Cadila Healthcare Ltd in Ahmedabad, India.
The recall was initiated after a pharmacist reported a product complaint stating that three tablets in a 1000-count bottle were oversized. This constitutes a failure of tablet specifications.
Consumers and healthcare providers should check their inventory for this specific product and lot number (MM5767). If found, the product should be returned to the pharmacy or Zydus Pharmaceuticals for disposal or credit.
The recalled product
- Product
- Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Anticoagulant
- Hazard
- Affected units
- 960
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 (1)
- Lot MM5767
Distribution
Distributed nationwide across the United States.
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