Drug product
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67
D-0321-2024
Product summary
- Event
- Event 93867
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 12,916 cartons
- Official record key
drug-enforcement:D-0321-2024
Official wording
Reason: Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Code information: Lot #: 100042978, Exp 7/31/2024
Distribution pattern: nationwide
Derived failure modes
-
Unknown
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.