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
- Recalling Firm
- Teva Pharmaceuticals USA, Inc.
- 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.
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