Norethindrone Acetate And Ethinyl Estradiol Tablet
FDA Recall NDC 0378-7280
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Norethindrone Acetate And Ethinyl Estradiol (NDC 0378-7280). A significant event, classified as Class III, was initiated on Jan 30, 2017 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
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.
Jan 30, 2017
May 31, 2017
8,605 cartons
Recall Profile & Regulatory Data
Event ID
77065
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Mylan Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in USA
Termination Date
Jun 01, 2017
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.
Batch or Lot Expiration Information
Lot# : 6327A006, Exp 02/18
Affected Packages Involved in this Recall
0378-7280-85Product
0378-7280-53Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
