Class III
Terminated
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.
- Company
- Mylan Pharmaceuticals Inc.
- Recall Initiated
- January 30, 2017
- Posted
- May 31, 2017
- Recall Number
- D-0860-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 43,848 cartons
- Firm Location
- Morgantown, WV, United States
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
Nationwide in USA
Lot / Code Info
Lot #: 6843F002D, Exp 02/18
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