Why it was recalled
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Product description
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged in 3 pouches, each contains one blister pack of 21 tablets (NDC 0378-7280-53), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India.
Lot numbers, UPCs & expiration codes
Lot #: 6327A006, Exp 02/18
Where it was sold
Nationwide in USA
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-0861-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 30, 2017
- FDA report date
- May 31, 2017
- Quantity
- 8,605 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0861-2017, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 77065
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot #: 6327A006, Exp 02/18
- Postal code
- 26505-2730
- Report date
- May 31, 2017
- Product type
- Drugs
- Recall number
- D-0861-2017
- Classification
- Class III
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 8,605 cartons
- Termination date
- Jun 1, 2017
- Reason for recall
- Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged in 3 pouches, each contains one blister pack of 21 tablets (NDC 0378-7280-53), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India.
- Distribution pattern
- Nationwide in USA
- Recall initiation date
- Jan 30, 2017
- Initial firm notification
- Center classification date
- May 23, 2017