Home / Recalls / Mylan Pharmaceuticals Inc. / D-0025-2019

D-0025-2019 Class III Terminated

Recalled by Mylan Pharmaceuticals Inc. — Morgantown, WV

Recall Details

Product Type
Drugs
Report Date
October 24, 2018
Initiation Date
August 27, 2018
Termination Date
July 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

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