Why it was recalled
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # 8508F004A; Exp. 02/20
Where it was sold
Product was distributed throughout the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0025-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 27, 2018
- FDA report date
- Oct 24, 2018
- Quantity
- 5,790 cartons (526,890 tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0025-2019, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 81221
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot # 8508F004A; Exp. 02/20
- Postal code
- 26505-2730
- Report date
- Oct 24, 2018
- Product type
- Drugs
- Recall number
- D-0025-2019
- Classification
- Class III
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 5,790 cartons (526,890 tablets)
- Termination date
- Jul 26, 2019
- Reason for recall
- Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Product was distributed throughout the United States.
- Recall initiation date
- Aug 27, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 14, 2018