FDA Drug Class II — Moderate

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.

Hazard

Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.

Products

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, Manufact
Brand
Teva Pharmaceuticals USA
UPC
Lot # 33809881A, Exp 05/17; 33811151A, Exp 08/17

Units Affected

17,473 cartons