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.
Reported: February 22, 2017 Initiated: February 2, 2017 #D-0479-2017
Product Description
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.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 17,473 cartons
- Distribution
- Nationwide in the United States
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teva Pharmaceuticals USA. Units affected: 17,473 cartons.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 22, 2017. Severity: Moderate. Recall number: D-0479-2017.
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