PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: July 4, 2012 Initiated: May 2, 2012 #D-1397-2012

Product Description

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

Reason for Recall

Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.

Details

Units Affected
100,761 cartons
Distribution
Nationwide
Location
Sellersville, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by Teva Pharmaceuticals USA, Inc.. Units affected: 100,761 cartons.
Why was this product recalled?
Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 4, 2012. Severity: Moderate. Recall number: D-1397-2012.