Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufa
Summary
The FDA issued a Class III for Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged i by Teva Pharmaceuticals USA. Reason: Mislabeling.
Details
Source
Drug Recall
External ID
D-0522-2022
Action Date
2022-02-09
Status
Terminated
Category
drug
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
Lot/Code Info: Lot#: 100018610, Exp 03/2022; 100021521, Exp 09/2022; 100024575, Exp 01/2023
Quantity Affected: 6430 cartons
Reason for Recall
Mislabeling
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-07
Company
Parsippany, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 136 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Teva Pharmaceuticals USA has 38 FDA actions in our database, including 38 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Teva Pharmaceuticals USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teva Pharmaceuticals USA have FDA actions?
Teva Pharmaceuticals USA has 38 FDA actions in our database, including 38 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0522-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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