Recalls / Class II
Class IID-0732-2016
Product
Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89
- Brand name
- Capecitabine
- Generic name
- Capecitabine
- Active ingredient
- Capecitabine
- Route
- Oral
- NDCs
- 0093-7473, 0093-7474
- FDA application
- ANDA091649
- Affected lot / code info
- Lot # 3A404012V, Exp. 4/2016
Why it was recalled
Failed Dissolution Specifications: low test results at the 18 month time-point
Recalling firm
- Firm
- Teva North America
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, N/A, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 1,895 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-12-21
- FDA classified
- 2016-03-01
- Posted by FDA
- 2016-03-09
- Terminated
- 2017-01-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0732-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.