# FDA recall D-1343-2014

> **Fresenius Medical Care Holdings, Inc.** · Class II · drug recall initiated 2014-04-14.

## Product

phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 02451, NDC 0781-2081-02

## Reason for recall

Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle.  Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepressant..

## Distribution

PA

## Key facts

- **Recall number:** D-1343-2014
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-04-14
- **Report date:** 2014-05-28
- **Termination date:** 2015-08-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1343-2014

## Citation

> AI Analytics. FDA recall D-1343-2014. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/D-1343-2014. Source: US FDA. Licensed CC0.

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