Drug product
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.
D-0479-2017
Product summary
- Event
- Event 76383
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,473 cartons
- Official record key
drug-enforcement:D-0479-2017
Official wording
Reason: Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Code information: Lot # 33809881A, Exp 05/17; 33811151A, Exp 08/17
Distribution pattern: Nationwide in the United States
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications