Drug 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.
D-0860-2017
Product summary
- Event
- Event 77065
- Status
- Terminated
- Classification
- Class III
- Quantity
- 43,848 cartons
- Official record key
drug-enforcement:D-0860-2017
Official wording
Reason: 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.
Code information: Lot #: 6843F002D, Exp 02/18
Distribution pattern: Nationwide in USA
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination
-
Potency or specification failure
out of specification