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
Reported: March 9, 2016 Initiated: December 21, 2015 #D-0732-2016
Product Description
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
Reason for Recall
Failed Dissolution Specifications: low test results at the 18 month time-point
Details
- Recalling Firm
- Teva North America
- Units Affected
- 1,895 bottles
- Distribution
- Nationwide
- Location
- Horsham, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva North America. Units affected: 1,895 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: low test results at the 18 month time-point
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 9, 2016. Severity: Moderate. Recall number: D-0732-2016.
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