# FDA recall D-1397-2012

> **Teva Pharmaceuticals USA, Inc.** · Class II · drug recall initiated 2012-05-02.

## 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

## Reason for recall

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

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1397-2012
- **Recalling firm:** Teva Pharmaceuticals USA, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-05-02
- **Report date:** 2012-07-04
- **Termination date:** 2013-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sellersville, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1397-2012

## Citation

> AI Analytics. FDA recall D-1397-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1397-2012. Source: US FDA. Licensed CC0.

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