D-0521-2022 Class III Terminated
FDA drug recall D-0521-2022 was initiated by Teva Pharmaceuticals USA on Jan 7, 2022 and is designated Class III. Reason for recall: Mislabeling The recall status is terminated (terminated Jun 1, 2023). Affected quantity: 218174 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 9, 2022
- Initiation Date
- Jan 7, 2022
- Termination Date
- Jun 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 218174 cartons
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
Reason for Recall
Mislabeling
Distribution Pattern
USA Nationwide
Code Information
Lot#: 100018611, Exp 03/2022; 100019834, Exp 06/2022; 100022226, Exp 09/2022; 100024574, Exp 01/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0521-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026