When the FDA put Teva’s sterile manufacturing site in Hungary on its import alert list in May, it banned all but two of its products, cancer treatment bleomycin and antibiotic amikacin. The exclusions didn’t mean the FDA didn’t have some concerns with those drugs, and now the drugmaker is expanding a recall of the antibiotic.
Teva ($TEVA) said last week it was recalling 7 additional lots of amikacin sulfate due to the potential for the presence of glass particulate, which it said could cause reactions from swelling to blood clots. It said it had not received any reports of adverse reactions to the product.
When Teva first recalled a lot of the antibiotic in March, it indicated that it was manufactured at its plant in Gödöllő, Hungary. The company had temporarily halted production at the plant in January after an inspection cited it with a number of shortcomings. The agency followed that up with the ban in May.
After the FDA banned products from the Hungary plant, Teva said it was “working around the clock to restart manufacturing operations as soon as possible, and are working cooperatively with regulatory authorities to minimize any potential impact on product availability.”
That impact was particularly hard on Hungary, which lost access to about 200 drugs as a result of the shutdown. The Hungary drug regulator said it was getting weekly updates from Teva about the situation so that it could avoid shortages, particularly of cancer and morphine drugs.
thanks to: FiercePharma