Recalls / Class I
Class ID-838-2013
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- Lot MM5767
Why it was recalled
Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 960 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-05-13
- FDA classified
- 2013-08-02
- Posted by FDA
- 2013-08-14
- Terminated
- 2015-05-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-838-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.