Class II
Terminated
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.
This recall has been terminated (originally issued February 22, 2017).
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- February 2, 2017
- Posted
- February 22, 2017
- Recall Number
- D-0479-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 17,473 cartons
- Firm Location
- North Wales, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Distribution
Nationwide in the United States
Lot / Code Info
Lot # 33809881A, Exp 05/17; 33811151A, Exp 08/17
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