Reported Oct 24, 2018 · Terminated

Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing…

Mylan Pharmaceuticals Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mylan Pharmaceuticals Inc. · 781 Chestnut Ridge Rd · Morgantown, WV · 26505-2730

Is this the product you have?

  • 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 forMylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7281-53
Lot codes and dates
    • Lot # 8508F004A
    • Exp. 02/20
Amount recalled
5,790 cartons (526,890 tablets)

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 26, 2019 · Data as of Sep 19, 8:04 PM UTC

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