# FDA recall D-1813-2015

> **EMD Serono, Inc.** · Class III · drug recall initiated 2015-09-10.

## Product

ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD., Jerusalem, 91010, Israel; Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA  18960; NDC 0093-0041-03, UPC 3 0093-0041-03 7.

## Reason for recall

Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1813-2015
- **Recalling firm:** EMD Serono, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-09-10
- **Report date:** 2015-09-23
- **Termination date:** 2017-02-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rockland, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1813-2015

## Citation

> AI Analytics. FDA recall D-1813-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1813-2015. Source: US FDA. Licensed CC0.

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