# FDA recall D-0006-2015

> **Janssen Ortho L.L.C.** · Class II · drug recall initiated 2014-09-17.

## Product

Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99

## Reason for recall

Microbial Contamination of Non-Sterile Products:  Consumer complaint confirmed microbial contamination in sales sample.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0006-2015
- **Recalling firm:** Janssen Ortho L.L.C.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-09-17
- **Report date:** 2014-10-15
- **Termination date:** 2016-10-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0006-2015

## Citation

> AI Analytics. FDA recall D-0006-2015. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/D-0006-2015. Source: US FDA. Licensed CC0.

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