Home / Recalls / Teva North America / D-0732-2016

D-0732-2016 Class II Terminated

Recalled by Teva North America — Horsham, PA

Recall Details

Product Type: Drugs
Report Date: March 9, 2016
Initiation Date: December 21, 2015
Termination Date: January 13, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,895 bottles

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

Distribution Pattern

Nationwide

Code Information

Lot # 3A404012V, Exp. 4/2016

Other recalls by Teva North America

D-0005-2017 Class III — Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Bli (August 5, 2016)
D-1453-2016 Class III — Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per (July 15, 2016)
D-1470-2016 Class II — Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufa (June 24, 2016)
D-1455-2016 Class II — Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Can (June 22, 2016)
D-1495-2016 Class II — Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHAR (June 17, 2016)
D-1494-2016 Class II — ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, (June 17, 2016)
D-1496-2016 Class II — Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenou (June 17, 2016)
D-1497-2016 Class II — Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungar (June 17, 2016)
D-1451-2016 Class III — mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple (May 31, 2016)
D-1449-2016 Class III — Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Ma (May 18, 2016)