The Recall Desk

FDA (Drugs) recall action 77065

Mylan Pharmaceuticals Inc. recalled 2 products on 2017-05-31

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2017-05-31
Critical
0
Units
52,453

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Drugs)··2017-05-31

    Mylan Recalls Tarina Fe 1/20 Tablets Due to Chemical Contamination

    Mylan Pharmaceuticals is recalling Tarina Fe 1/20 tablets due to chemical contamination from paint thinner vapors during manufacturing.

    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
    Category
    Distribution
    0 states