FDA recall D-0522-2022

Product

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

Reason for recall

Mislabeling

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2022-01-07

Report date

2022-02-09

Termination date

2023-06-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0522-2022