Mylan Pharmaceuticals Inc. recalls Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7
Recalled May 31, 2017 · FDA recall D-0861-2017 · Mylan Pharmaceuticals
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. · FDA Class III
Units
8,605 cartons
Sold at
Nationwide in USA
Description
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
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.
Manufacturer(s)
Mylan Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →