Drug product
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.
D-0861-2017
Product summary
- Event
- Event 77065
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8,605 cartons
- Official record key
drug-enforcement:D-0861-2017
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 #: 6327A006, 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