Class II
Terminated
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
This recall has been terminated (originally issued March 9, 2016).
- Company
- Teva North America
- Recall Initiated
- December 21, 2015
- Posted
- March 9, 2016
- Recall Number
- D-0732-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,895 bottles
- Firm Location
- Horsham, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications: low test results at the 18 month time-point
Distribution
Nationwide
Lot / Code Info
Lot # 3A404012V, Exp. 4/2016
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