Mylan Pharmaceuticals Inc. recalls Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-…

Recall date

January 30, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0861-2017

FDA classification

Class III

Brand / firm

Mylan Pharmaceuticals Inc.

Sold / distributed

Nationwide in USA

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.