Drug recall D-0861-2017
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.
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.
Lots and codes
Lot #: 6327A006, Exp 02/18
Recall details
- Recalling firm
- Mylan Pharmaceuticals Inc., Morgantown, WV
- Quantity
- 8,605 cartons
- Distribution
- Nationwide in USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 30, 2017
- Terminated
- June 1, 2017
Related products
- Norethindrone Acetate and Ethinyl Estradiol – drug information
- NDC 0378-7280 Norethindrone Acetate And Ethinyl Estradiol · Ethinyl Estradiol .02 mg/1; Norethindrone Acetate 1 mg/1 · Mylan Pharmaceuticals Inc.