FDA-Drug2017-02-22Class II
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.
Teva Pharmaceuticals USA
Hazard
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Sold states
Nationwide in the United States
Affected count
17,473 cartons
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
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, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0479-2017Don't want to check this manually?
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