# FDA recall D-0410-2015

> **Fusion Pharmaceuticals, LLC** · Class II · drug recall initiated 2015-03-06.

## Product

DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only.  Fusion Pharmaceuticals LLC., 768 Calle Plano, Camarillo, CA 93012. NDC: 43093-104-01.

## Reason for recall

Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.

## Distribution

California

## Key facts

- **Recall number:** D-0410-2015
- **Recalling firm:** Fusion Pharmaceuticals, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-03-06
- **Report date:** 2015-03-18
- **Termination date:** 2015-10-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Camarillo, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0410-2015

## Citation

> AI Analytics. FDA recall D-0410-2015. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0410-2015. Source: US FDA. Licensed CC0.

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