FDA-Drug2018-10-24Class III

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.

Mylan Pharmaceuticals Inc.
Hazard

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

Sold states
Product was distributed throughout the United States.
Affected count
5,790 cartons (526,890 tablets)
Manufactured in
781 Chestnut Ridge Rd, N/A, Morgantown, WV, United States
Products
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.

Official notice

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

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