Teva Recalls Four Drugs Produced at Hungary Plant
Teva has recalled four injected drugs made at its plant in Hungary after an FDA ban on imports from the plant.
Teva has recalled 92,480 containers of the antibiotic linezolid; 14,661 vials of the heart surgery drug eptifibatide; 13,223 vials of the anti-nausea drug ondansetron and 1,299 bags of argatroban, which is used for heparin-related issues.
According to Teva, the recalls began in June, but the FDA didn’t give the recall a class II designation until earlier this month.
Teva’s. $110 million, 15,000-square-meter sterile injectables plant in Godollo, Hungary, opened in 2012. The plant has six production lines and the capacity to produce 160 million to 200 million units of injectable medications annually. The FDA shut the plant down temporarily after an inspection in January exposed a number of manufacturing issues.