Drugplain

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

norethindrone acetate and ethinyl estradiol · KIT · Mylan Pharmaceuticals Inc.

9 Recalls on Record
Plain English

Norethindrone acetate and ethinyl estradiol is a combination birth control medication used to prevent pregnancy. This prescription medication contains two hormones that work together to stop ovulation and make it harder for sperm to reach an egg.

Key Facts

Brand Name
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Generic Name
norethindrone acetate and ethinyl estradiol
NDC Code (Product)
0378-7288
Manufacturer
Mylan Pharmaceuticals Inc.
Dosage Form
KIT
Marketing Status
Application #
ANDA202741
Marketing Start
12/16/2019

Recall History

9 Recalls on Record
Class III01/30/2017

Mylan Pharmaceuticals Inc.

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.

TerminatedVoluntary: Firm initiated
Class III02/15/2013

Warner Chilcott Company LLC

Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.

TerminatedVoluntary: Firm initiated
Class I05/16/2017

Lupin Limited (Unit 1)

Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.

TerminatedVoluntary: Firm initiated
Class III03/15/2013

Teva Pharmaceuticals USA, Inc.

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

TerminatedVoluntary: Firm initiated
Class III02/15/2013

Warner Chilcott Company LLC

Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.

TerminatedVoluntary: Firm initiated
Class III01/30/2017

Mylan Pharmaceuticals Inc.

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.

TerminatedVoluntary: Firm initiated
Class II07/21/2020

Lupin Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.

TerminatedVoluntary: Firm initiated
Class II12/26/2019

Lupin Pharmaceuticals Inc.

Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.

TerminatedVoluntary: Firm initiated
Class III02/15/2013

Warner Chilcott Company LLC

Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL used for?

Norethindrone acetate and ethinyl estradiol is a combination birth control medication used to prevent pregnancy. This prescription medication contains two hormones that work together to stop ovulation and make it harder for sperm to reach an egg.

Is NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL a controlled substance?

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL is not classified as a controlled substance by the DEA.

What is the generic name for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL?

The generic name for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL is norethindrone acetate and ethinyl estradiol. There are 12 other brand versions of norethindrone acetate and ethinyl estradiol.

What is the NDC code for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ?

The NDC (National Drug Code) for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL is 0378-7288, listed by Mylan Pharmaceuticals Inc..