August 2018 FDA Recall Drug by Mylan Pharmaceuticals Inc.
D-0025-2019 - Labeling

This Class III drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on August 27, 2018 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Product was distributed throughout the United States. and the recall is currently terminated.

Recall Number: D-0025-2019

Reason for Recall
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Initiated
08-27-2018
Reported
10-24-2018
Quantity
5,790 cartons (526,890 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81221
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mylan Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-26-2019
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 8508F004A; Exp. 02/20