Mimvey Tablet, Film Coated
FDA Recall NDC 0093-5455
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Mimvey (NDC 0093-5455). A significant event, classified as Class III, was initiated on Jan 07, 2022 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Mislabeling"
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
Mislabeling
Jan 07, 2022
Feb 09, 2022
6430 cartons
Recall Profile & Regulatory Data
Event ID
89368
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Jun 01, 2023
Product Description
Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-42
Batch or Lot Expiration Information
Lot# : 100018610, Exp 03/2022; 100021521, Exp 09/2022; 100024575, Exp 01/2023
Affected Packages Involved in this Recall
0093-5455-28Product
0093-5455-42Product
Class III Terminated
Mislabeling
Jan 07, 2022
Feb 09, 2022
218174 cartons
Recall Profile & Regulatory Data
Event ID
89368
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Jun 01, 2023
Product Description
Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-28
Batch or Lot Expiration Information
Lot# : 100018611, Exp 03/2022; 100019834, Exp 06/2022; 100022226, Exp 09/2022; 100024574, Exp 01/2023
Affected Packages Involved in this Recall
0093-5455-28Product
0093-5455-42Product
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.
