# FDA recall D-142-2013

> **Warner Chilcott Company LLC** · Class III · drug recall initiated 2012-12-21.

## Product

Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738

## Reason for recall

Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles

## Distribution

US Nationwide

## Key facts

- **Recall number:** D-142-2013
- **Recalling firm:** Warner Chilcott Company LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-12-21
- **Report date:** 2013-02-06
- **Termination date:** 2015-06-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fajardo, PR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-142-2013

## Citation

> AI Analytics. FDA recall D-142-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-142-2013. Source: US FDA. Licensed CC0.

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