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Imports banned from Teva’s Hungary Plant by FDA except for two drugs in shortage

The US FDA has announced an import alert prohibiting drugs made at the Godollo, Hungary-based manufacturing site from entering the US. The import alert has been issued on May 27.Teva is a $110 million manufacturing facility responsible for producing sterile injectable drugs, and with six production lines.

The ban does not include two drugs that are medically necessary and currently in short supply in the US. Those two drugs are the Amikacin used for the treatment of infection and the Bleomycin used in chemotherapy.

Although it was not clear as to why an import alert has been issued by FDA, but it is presumed that Teva received a Form 483, usually the document outlining initial good manufacturing practice violations that precedes a warning letter, for the site in January, as well as in 2007.


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