Mylan Pharmaceuticals Inc. recalls Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack c
Recalled May 31, 2017 · FDA recall D-0860-2017 · 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
43,848 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
Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablets (NDC 50102-128-01), packaged in 3 pouches, each pouch contains one blister pack of 28 tablets (NDC 50102-128-03), Rx only, Manufactured for: Afaxys, Inc., Charleston, SC 29403, USA, Product of India.
Manufacturer(s)
Mylan Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →