D-0025-2019 Class III Terminated
FDA drug recall D-0025-2019 was initiated by Mylan Pharmaceuticals Inc. on Aug 27, 2018 and is designated Class III. Reason for recall: Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs. The recall status is terminated (terminated Jul 26, 2019). Affected quantity: 5,790 cartons (526,890 tablets).
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 24, 2018
- Initiation Date
- Aug 27, 2018
- Termination Date
- Jul 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,790 cartons (526,890 tablets)
Product Description
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.
Reason for Recall
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Distribution Pattern
Product was distributed throughout the United States.
Code Information
Lot # 8508F004A; Exp. 02/20
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0025-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026