Key Takeaway

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 Ph by Teva Pharmaceuticals USA was recalled on January 7, 2022. The hazard: Mislabeling

FDA Drug Class III Terminated

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 Ph

Recalled: January 7, 2022 ~218174 cartons units affected D-0521-2022

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

Hazard / Reason

Mislabeling

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

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 Ph

Drugs

Company Information

Teva Pharmaceuticals USA

Horsham, PA, United States

View all 196 recalls by Teva Pharmaceuticals USA →

Distribution

USA Nationwide

Related Recalls

FDA Drug Class II

Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distri

January 18, 2022
FDA Drug Class II

Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02

January 10, 2022
FDA Drug Class III

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 Pha

January 7, 2022
FDA Drug Class II

Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-

December 31, 2021
FDA Drug Class II

MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceutic

December 31, 2021
FDA Drug Class II

Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmace

December 16, 2021

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.