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, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.
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
43,922 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, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0837-2018Don't want to check this manually?
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