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
FDA recall notice · announced March 9, 2016 · Teva
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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
Reason for recall
Failed Dissolution Specifications: low test results at the 18 month time-point
Notes
Distribution: Nationwide
Lot/code information: Lot # 3A404012V, Exp. 4/2016
Quantity: 1,895 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0732-2016)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.