# FDA recall D-0479-2017

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2017-02-02.

## Product

Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA  18960.

## Reason for recall

Failed Impurities/Degradation Specifications: out of  specification test results for the norethindrone impurity.

## Distribution

Nationwide in the United States

## Key facts

- **Recall number:** D-0479-2017
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-02-02
- **Report date:** 2017-02-22
- **Termination date:** 2018-02-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0479-2017

## Citation

> AI Analytics. FDA recall D-0479-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0479-2017. Source: US FDA. Licensed CC0.

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