Recalls / Class III
Class IIID-0521-2022
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 0093-5455-28
- Brand name
- Mimvey
- Generic name
- Estradiol And Norethindrone Acetate
- Active ingredients
- Estradiol, Norethindrone Acetate
- Route
- Oral
- NDC
- 0093-5455
- FDA application
- ANDA079193
- Affected lot / code info
- Lot#: 100018611, Exp 03/2022; 100019834, Exp 06/2022; 100022226, Exp 09/2022; 100024574, Exp 01/2023
Why it was recalled
Mislabeling
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 218174 cartons
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2022-01-07
- FDA classified
- 2022-02-02
- Posted by FDA
- 2022-02-09
- Terminated
- 2023-06-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0521-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.