Teva continues to deal with the fallout from an FDA ban of its sterile injectables plant in Hungary and is now recalling all lots of four different injected drugs.
According to the most recent FDA Enforcement Report, the Teva Pharmaceutical ($TEVA) recall includes 92,480 containers of antibiotic linezolid; 14,661 vials of heart surgery drug eptifibatide; 13,223 vials of anti-nausea drug ondansetron and 1,299 bags of argatroban, used for treating heparin-related complications. The report says Teva began the recalls in June, although the FDA only last week gave them a class II designation.
The products all came out of Teva’a plant in Gödöllő, a relatively new facility which the company opened in 2012 to expand its injected drug capacity. The $110 million, 15,000-square-meter plant has 6 production lines and the capacity to churn out 160 million to 200 million units of injectable meds annually.
But those lines went idle earlier this year when Teva temporarily halted production following an FDA inspection in January that found a number of manufacturing issues. The FDA followed that up in late May when it issued an import alert for the facility, banning all but two essential products from the facility: cancer treatment bleomycin and antibiotic amikacin.
Teva in a statement today said it had begun recalling “all in-date lots” of the four in the US, “in order to ensure that disposition decisions for U.S. products manufactured at the Gödöllő site were in alignment with FDA’s import alert. In July, we recalled 7 lots of Amikacin for reasons unrelated to the import alert. This was an extension of a previous recall that Teva initiated in March. We are working around the clock to re-start manufacturing operations in Godollo and expect that to occur in the coming months.”
Teva has not specified the nature of the observations laid out in an FDA Form 483, but said it was working closely with the FDA to resolve the issues and return supplies of its products. It said in some cases it would look for alternative sources of supply. None of the four drugs is currently listed on the FDA’s drug shortages list. Teva has said that it is unaware of any adverse events tied to any of the drugs shipped from the facility.
The plant issues arose at a tricky time for Teva, which was in the midst of trying to close on its $40.5 billion purchase of the generics unit of Allergan ($AGN). After delays and an agreement with the FTC that is would divest 75 products, the deal closed last month.
– access the recalls here
thanks to: FiercePharma