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 # 8508F004AExp. 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.
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