Key Takeaway

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 Pharmaceutical by Teva Pharmaceuticals USA, Inc. was recalled on May 2, 2012. The hazard: Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.

FDA Drug 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 Pharmaceutical

Recalled: May 2, 2012 ~100,761 cartons units affected D-1397-2012

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

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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 Pharmaceutical

Drugs

Company Information

Teva Pharmaceuticals USA, Inc.

Sellersville, PA, United States

View all 69 recalls by Teva Pharmaceuticals USA, Inc. →

Distribution

Nationwide

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Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

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