Drug product
Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made in India, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7281-53.
D-0025-2019
Product summary
- Event
- Event 81221
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,790 cartons (526,890 tablets)
- Official record key
drug-enforcement:D-0025-2019
Official wording
Reason: Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Code information: Lot # 8508F004A; Exp. 02/20
Distribution pattern: Product was distributed throughout the United States.
Derived failure modes
-
Labeling or packaging
Labeling: Not Elsewhere Classified-Incorrect