FDA recall D-0025-2019

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.

Reason for recall

Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.

Distribution

Product was distributed throughout the United States.

Key facts

Status

Terminated

Initiation date

2018-08-27

Report date

2018-10-24

Termination date

2019-07-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0025-2019