FDAFDA · Alimentos y medicamentos·N.º oficial 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.

Name: 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.
Brand: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Publicado el 31 de mayo de 2017 · Inicio del retiro: 30 de enero de 2017

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · E-Mail

Detalles del retiro

Marca: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Fabricante: Mylan Pharmaceuticals Inc.
Distribuidor: Nationwide in USA
Lote: Lot #: 6327A006, Exp 02/18
Clasificación de riesgo: Class III
Área (FDA): drug
País: United States