Recalls / Class III
Class IIID-0860-2017
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.
- Affected lot / code info
- Lot #: 6843F002D, Exp 02/18
Why it was 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.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 43,848 cartons
- Distribution pattern
- Nationwide in USA
Timeline
- Recall initiated
- 2017-01-30
- FDA classified
- 2017-05-23
- Posted by FDA
- 2017-05-31
- Terminated
- 2017-06-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0860-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.