FDA recall D-0479-2017

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.

Reason for recall

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

Distribution

Nationwide in the United States

Key facts

Status

Terminated

Initiation date

2017-02-02

Report date

2017-02-22

Termination date

2018-02-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0479-2017