FDAFDA · Food and drugs·Recall number D-0861-2017
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.
Published May 31, 2017 · Recall initiated: January 30, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Distributor
- Nationwide in USA
- Lot
- Lot #: 6327A006, Exp 02/18
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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