Recalls / Class II
Class IID-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.
- Affected lot / code info
- Lot # 33809881A, Exp 05/17; 33811151A, Exp 08/17
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 17,473 cartons
- Distribution pattern
- Nationwide in the United States
Timeline
- Recall initiated
- 2017-02-02
- FDA classified
- 2017-02-16
- Posted by FDA
- 2017-02-22
- Terminated
- 2018-02-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0479-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.