Drug recall D-0025-2019

Class III Terminated reported Oct 24, 2018

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.

Lots and codes

Lot # 8508F004A; Exp. 02/20

Recall details

Recalling firm
Mylan Pharmaceuticals Inc., Morgantown, WV
Quantity
5,790 cartons (526,890 tablets)
Distribution
Product was distributed throughout the United States.
Type
Voluntary: Firm initiated
Recall initiated
August 27, 2018
Terminated
July 26, 2019