Drug product
Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-28
D-0521-2022
Product summary
- Event
- Event 89368
- Status
- Terminated
- Classification
- Class III
- Quantity
- 218174 cartons
- Official record key
drug-enforcement:D-0521-2022
Official wording
Reason: Mislabeling
Code information: Lot#: 100018611, Exp 03/2022; 100019834, Exp 06/2022; 100022226, Exp 09/2022; 100024574, Exp 01/2023
Distribution pattern: USA Nationwide
Derived failure modes
-
Labeling or packaging
Mislabeling