FDAFDA · Food and drugs·Recall number D-0025-2019
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.
Published October 24, 2018 · Recall initiated: August 27, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Distributor
- Product was distributed throughout the United States.
- Lot
- Lot # 8508F004A; Exp. 02/20
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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