The drug was not approved by US FDA
Lupin Pharmaceuticals has initiated voluntary recall of 43,922 cartons of My Way (levonorgestrel) tablets from the US market as they were not approved by the US health regulator. According to a notification by the US Food and Drug Administration, the drug belongs to Gavis Pharmaceuticals and is manufactured for Lupin Pharmaceuticals to market it in the US. Lupin acquired Gavis Pharmaceuticals in March 2016.
“Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release,” FDA said under Reason for Recall column. “My Way is an emergency contraceptive pill that helps prevent pregnancy after birth control failure or unprotected sex. It is a back up method of preventing pregnancy and is not to be used routinely,” FDA said.
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