Recalls / Class II
Class IID-1397-2012
Product
Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons containing three (3) individual blister packs
- Affected lot / code info
- Lot #'s 33800226A, Exp 7/2012; 33800333A, Exp 10/2012; 33800870A, Exp 10/2012; 33802533A, Exp 4/2013; and 33802720A, Exp 8/2013
Why it was recalled
Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 100,761 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-05-02
- FDA classified
- 2012-06-26
- Posted by FDA
- 2012-07-04
- Terminated
- 2013-04-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1397-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.