D-0861-2017 Class III Terminated
FDA drug recall D-0861-2017 was initiated by Mylan Pharmaceuticals Inc. on January 30, 2017 and is designated Class III. 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 manufacturin… The recall status is terminated (terminated June 1, 2017). Affected quantity: 8,605 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- May 31, 2017
- Initiation Date
- January 30, 2017
- Termination Date
- June 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,605 cartons
Product Description
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.
Distribution Pattern
Nationwide in USA
Code Information
Lot #: 6327A006, Exp 02/18