FDA-Drug2018-05-30Class II
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.
Lupin Pharmaceuticals Inc.
Hazard
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Sold states
Nationwide in the USA
Affected count
43,640 cartons
Manufactured in
111 S Calvert St Fl 21ST, N/A, Baltimore, MD, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0838-2018Don't want to check this manually?
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