FDA recall D-0410-2015

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

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

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