FDAFDA · Food and drugs·Recall number D-0479-2017
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.
Published February 22, 2017 · Recall initiated: February 2, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Nationwide in the United States
- Lot
- Lot # 33809881A, Exp 05/17; 33811151A, Exp 08/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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