Lupin Pharmaceuticals Inc. recalls My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per c
Recalled May 30, 2018 · FDA recall D-0838-2018 · Lupin Pharmaceuticals
Hazard
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release. · FDA Class II
Units
43,640 cartons
Sold at
Nationwide in the USA
Description
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Product
My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, INDIA, UPC 3 68180 85212 4.
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →