Home / Recalls / Mylan Pharmaceuticals Inc. / D-0861-2017

D-0861-2017 Class III Terminated

Recalled by Mylan Pharmaceuticals Inc. — Morgantown, WV

Recall Details

Product Type
Drugs
Report Date
May 31, 2017
Initiation Date
January 30, 2017
Termination Date
June 1, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,605 cartons

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide in USA

Code Information

Lot #: 6327A006, Exp 02/18

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