Two lots of an oral contraceptive pill have been recalled in the US, with the FDA warning these may have reduced effectiveness and resulted in unexpected pregnancies.
The FDA’s announcement came after Lupin Pharmaceuticals voluntarily recalled two batches of Tydemy over concerns it contained insufficient amounts of ascorbic acid, reports The Washington Post.
Lupin also noted that one lot tested “high for a known impurity,” although it wasn’t clear what the impurity was.
The recall involves almost 4 200 boxes of the drug, according to FDA data.
Lupin Pharmaceuticals is the US subsidiary of Lupin, an Indian generic pharmaceutical company. It received FDA approval to market Tydemy, a generic version of Bayer’s Safyral, in 2017.
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