D-0861-2017 Class III Terminated
FDA drug recall D-0861-2017 was initiated by Mylan Pharmaceuticals Inc. on Jan 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… The recall status is terminated (terminated Jun 1, 2017). Affected quantity: 8,605 cartons.
Recall details
- Product Type
- Drugs
- Report Date
- May 31, 2017
- Initiation Date
- Jan 30, 2017
- Termination Date
- Jun 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0861-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026