Product: My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD  21202, UPC 3 43386-622-31 3.
Reason for recall: Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Recall initiated: 20180517
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated