Mylan Recalls Levonorgestrel and Ethinyl Estradiol Tablets Due to Labeling Errors
Mylan Pharmaceuticals is recalling specific lots of levonorgestrel and ethinyl estradiol tablets because the blister packs display incorrect NDC and product name information.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is limited to packaging labeling errors.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 5,790 cartons (526,890 tablets) of Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only. The affected product consists of 3 extended-cycle blister packs containing 91 tablets each, manufactured in India for Mylan Pharmaceuticals Inc. in Morgantown, WV. The specific lot number is 8508F004A with an expiration date of 02/20.
The recall was initiated due to a labeling error where the blister packs identified an incorrect NDC and product name. This is classified as a Class III recall by the U.S. Food and Drug Administration, indicating that the product is not likely to cause adverse health consequences or death.
The product was distributed throughout the United States. Consumers and healthcare providers should check their inventory for the specific lot number and NDC 0378-7281-53. If the product matches the description, it should be returned to the pharmacy or point of purchase for disposal or replacement.
The recalled product
- 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.
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Oral Contraceptives
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 8508F004A
- Exp. 02/20
Distribution
Distribution scope not specified by the agency.
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