Why it was recalled
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 0093-5455-28
Lot numbers, UPCs & expiration codes
Lot#: 100018611, Exp 03/2022; 100019834, Exp 06/2022; 100022226, Exp 09/2022; 100024574, Exp 01/2023
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0521-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 7, 2022
- FDA report date
- Feb 9, 2022
- Quantity
- 218174 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0521-2022, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89368
- Address
- 400 Interpace Pkwy
- Code information
- Lot#: 100018611, Exp 03/2022; 100019834, Exp 06/2022; 100022226, Exp 09/2022; 100024574, Exp 01/2023
- Postal code
- 07054-1120
- Report date
- Feb 9, 2022
- Product type
- Drugs
- Recall number
- D-0521-2022
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 218174 cartons
- Termination date
- Jun 1, 2023
- Reason for recall
- Mislabeling
- Voluntary / mandated
- Voluntary: Firm initiated
- 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 0093-5455-28
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jan 7, 2022
- Initial firm notification
- Letter
- Center classification date
- Feb 2, 2022