Drug 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.
D-0837-2018
Product summary
- Event
- Event 80097
- Status
- Terminated
- Classification
- Class II
- Quantity
- 43,922 cartons
- Official record key
drug-enforcement:D-0837-2018
Official wording
Reason: Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Code information: Lot #: M16317A1, M16317A4, M16317A5, Exp 11/18
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.