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.

Recall Number: D-0410-2015

Firm: Fusion Pharmaceuticals, LLC

Classification: Class II

Status: Terminated

Report Date: 20150318

Initiation Date: 20150306

Termination Date: 20151027

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

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.