D-0479-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 22, 2017
- Initiation Date
- February 2, 2017
- Termination Date
- February 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,473 cartons
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.
Reason for Recall
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Distribution Pattern
Nationwide in the United States
Code Information
Lot # 33809881A, Exp 05/17; 33811151A, Exp 08/17