Teva Pharmaceuticals USA: Drug Recall

Recall #D-0522-2022 · 01/07/2022

Class III: Low Risk

Recall Details

Recall Number: D-0522-2022
Classification: Class III
Product Type: Drug
Recalling Firm: Teva Pharmaceuticals USA
Status: Terminated
Date Initiated: 01/07/2022
Location: Parsippany, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6430 cartons

Reason for Recall

Mislabeling

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

Distribution Pattern

USA Nationwide

Other Recalls by Teva Pharmaceuticals USA

Class II: Risk 01/18/2022

Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Class II: Risk 01/10/2022

Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Class III: Low Risk 01/07/2022

Mislabeling
Class II: Risk 12/31/2021

Lack of Assurance of Sterility
Class II: Risk 12/31/2021

Lack of Assurance of Sterility

View all recalls by Teva Pharmaceuticals USA →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.