Drug 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.
D-0838-2018
Product summary
- Event
- Event 80097
- Status
- Terminated
- Classification
- Class II
- Quantity
- 43,640 cartons
- Official record key
drug-enforcement:D-0838-2018
Official wording
Reason: Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Code information: Lot #: L700329, Exp 08/19; L700670, Exp 11/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.