Why it was recalled
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Product description
Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.
Lot numbers, UPCs & expiration codes
Lot # 33809881A, Exp 05/17; 33811151A, Exp 08/17
Where it was sold
Nationwide in the United States
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-0479-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 2, 2017
- FDA report date
- Feb 22, 2017
- Quantity
- 17,473 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0479-2017, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 76383
- Address
- 1090 Horsham Rd
- Code information
- Lot # 33809881A, Exp 05/17; 33811151A, Exp 08/17
- Postal code
- 19454-1505
- Report date
- Feb 22, 2017
- Product type
- Drugs
- Recall number
- D-0479-2017
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 17,473 cartons
- Termination date
- Feb 6, 2018
- Reason for recall
- Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.
- Distribution pattern
- Nationwide in the United States
- Recall initiation date
- Feb 2, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 16, 2017